bioscience research journal publication fee

Fees and funding

Article processing charges (apc).

Authors who publish open access in Biological Research are required to pay an article processing charge (APC). The APC price will be determined from the date on which the article is accepted for publication.

The current APC, subject to VAT or local taxes where applicable, is: £2090.00/$2790.00/€2390.00

Visit our open access support portal and our Journal Pricing FAQs for further information.

Open access funding

Visit Springer Nature’s open access funding & support services for information about research funders and institutions that provide funding for APCs.

Springer Nature offers agreements that enable institutions to cover open access publishing costs. Learn more about our open access agreements to check your eligibility and discover whether this journal is included.

Springer Nature offers APC waivers and discounts for articles published in our fully open access journals whose corresponding authors are based in the world’s lowest income countries (see our APC waivers and discounts policy for further information). Requests for APC waivers and discounts from other authors will be considered on a case-by-case basis, and may be granted in cases of financial need (see our open access policies for journals for more information). All applications for discretionary APC waivers and discounts should be made at the point of manuscript submission; requests made during the review process or after acceptance are unable to be considered.

Annual Journal Metrics

Citation Impact 2023 Journal Impact Factor: 4.3 5-year Journal Impact Factor: 6.6 Source Normalized Impact per Paper (SNIP): 1.354 SCImago Journal Rank (SJR): 1.300 Speed 2023 Submission to first editorial decision (median days): 22 Submission to acceptance (median days): 155 Usage 2023 Downloads: 489,080 Altmetric mentions: 731

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Biological Research

ISSN: 0717-6287

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General enquiries: [email protected]

Bioscience Research impact factor, indexing, ranking (2024)

Aim and Scope

The Bioscience Research is a research journal published by the Innovative Scientific Information & Services network (ISISnet). The P-ISSN of this journal is 18119506.

Important Metrics

	Bioscience Research
	Innovative Scientific Information & Services network (ISISnet)
	18119506

	Inactive
	2007-2018

bioscience research Indexing

The bioscience research is indexed in:

The journal is discontinued by the Scopus.

An indexed journal means that the journal has gone through and passed a review process of certain requirements done by a journal indexer.

The Web of Science Core Collection includes the Science Citation Index Expanded (SCIE), Social Sciences Citation Index (SSCI), Arts & Humanities Citation Index (AHCI), and Emerging Sources Citation Index (ESCI).

Journal Publication Time

The publication time may vary depending on factors such as the complexity of the research and the current workload of the editorial team. Journals typically request reviewers to submit their reviews within 3-4 weeks. However, some journals lack mechanisms to enforce this deadline, making it difficult to predict the duration of the peer review process.

The review time also depends upon the quality of the research paper.

Call for Papers

Visit to the official website of the journal/ conference to check the details about call for papers.

How to publish in Bioscience Research?

If your research is related to the scope of the journal, then visit the official website of bioscience research and send your manuscript.

Tips for publishing in Bioscience Research:

Selection of research problem.
Presenting a solution.
Designing the paper.
Make your manuscript publication worthy.
Write an effective results section.
Mind your references.

Acceptance Rate

Final summary.

It is published by Innovative Scientific Information & Services network (ISISnet) .
The journal is indexed in NA .

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Instructions to Authors

About the journal.

Bioscience, Biotechnology, and Biochemistry is a peer-reviewed journal that publishes 12 issues per year online.

Papers in Bioscience, Biotechnology, and Biochemistry may have associated charges. Please refer to the Charges section below.

Please read these instructions carefully and follow them closely. The Editors may return manuscripts that do not follow these instructions. Note that for new submissions of Regular Papers, authors may submit papers in any journal format and style. Manuscripts should, however, still contain the basic elements comprising an appropriate title, author list, abstract, main document and references. Whichever reference style the author uses must be consistent throughout the manuscript. Papers being resubmitted after revision are still required to be carefully prepared according to the formatting guidelines set out in the instructions below.

Scope of the Journal

Bioscience, Biotechnology, and Biochemistry publishes high-quality papers providing chemical and biological analyses of vital phenomena exhibited by animals, plants, and microorganisms, the chemical structures and functions of their products, and related matters. The journal plays a major role in communicating to a global audience outstanding basic and applied research in all fields subsumed by the Japan Society for Bioscience, Biotechnology, and Agrochemistry (JSBBA).

It publishes articles on organic and bioorganic chemistry, enzymology, animal science, physical and analytical chemistry, biopolymer science, food science, microbiology (including virology), plant science, and environmental science.

Editorial Policies

Peer review.

Bioscience, Biotechnology, and Biochemistry uses single blind peer review. For full details about the peer review process, see Fair editing and peer review .

All persons designated as authors should qualify for authorship. The entitlement to authorship should be based on all of the following criteria: (1) substantial contributions to conceptions and design, execution or analysis and interpretation of data; (2) drafting the article or revising it for important intellectual content; (3) final approval of the version to be published. Acquisition of funding, collection of data, or general supervision of the research group alone, does not justify authorship. All contributors who do not meet the criteria for authorship should be listed in the Acknowledgements. The order of authorship should be a joint decision between the co-authors. Each author should have participated sufficiently in the work to take public responsibility for the whole or part of the content.

The Journal does not allow ghost authorship, where an unnamed author prepares the article with no credit, or guest/gift authorship, where an author who made little or no contribution is listed as an author. The Journal follows Committee on Publication Ethics (COPE) guidance on investigating and resolving these cases. For more information, please see the OUP Publication Ethics page .

Natural language processing tools driven by artificial intelligence (AI) do not qualify as authors, and the Journal will screen for them in author lists. The use of AI (for example, to help generate content or images, write code, process data, or for translation) should be disclosed both in cover letters to editors and in the Methods or Acknowledgements section of manuscripts. Please see the COPE position statement on Authorship and AI for more details.

After manuscript submission, no authorship changes (including the authorship list, author order, and who is designated as the corresponding author) should be made unless there is a substantive reason to do so. The editor and all co-authors must agree on the change(s), and neither the Journal nor the publisher mediates authorship disputes. If individuals cannot agree on the authorship of a submitted manuscript, contact the editorial office at [email protected] . The dispute must be resolved among the individuals and their institution(s) before the manuscript can be accepted for publication. If an authorship dispute or change arises after a paper is accepted, contact OUP’s Author Support team. COPE provides guidance for authors on resolving authorship disputes.

After submission, changing who is designated as the corresponding author will be permitted only where there is a substantive reason to do so. For the avoidance of doubt, changing the corresponding author in order to access Read and Publish funding is not permissible. For more information on Read and Publish funding, see the Open access charges section.

Availability of Data and Materials

Where ethically feasible, Bioscience, Biotechnology, and Biochemistry strongly encourages authors to make all data and software code on which the conclusions of the paper rely available to readers. We suggest that data be presented in the main manuscript or additional supporting files, or deposited in a public repository whenever possible. Information on general repositories for all data types, and a list of recommended repositories by subject area, is available at Choosing where to archive your data .

Please note that, as part of the review process, authors may occasionally be requested to provide the raw data underpinning the findings in their paper. Failure or unwillingness to do so may result in the paper being rejected. We thank you in advance for your cooperation.

Data Availability Statement

Data Availability Statements provide a standardised format for readers to understand the availability of data underlying the research results described in the article. The statement may refer to original data generated in the course of the study or to third-party data analysed in the article. The statement should describe and provide means of access, where possible, by linking to the data or providing the required unique identifier.

The inclusion of a Data Availability Statement is mandatory for all original research articles (Regular Papers, Notes) published in Bioscience, Biotechnology, and Biochemistry. The Data Availability Statement should be included in the endmatter of your article under the heading ‘Data availability’.

More information and example Data Availability Statements can be found under the Data Availability Statements ( Bioscience, Biotechnology, and Biochemistry operates a Level 2 Data Policy) section.

Data Citation

Bioscience, Biotechnology, and Biochemistry supports the Force 11 Data Citation Principles and requires that all publicly available datasets be fully referenced in the reference list with an accession number or unique identifier such as a digital object identifier (DOI). Data citations should include the minimum information recommended by DataCite :

[dataset]* Authors, Year, Title, Publisher (repository or archive name), Identifier

*The inclusion of the [dataset] tag at the beginning of the citation helps us to correctly identify and tag the citation. This tag will be removed from the citation published in the reference list.

Preprint policy

Authors retain the right to make an Author’s Original Version (preprint) available through various channels, and this does not prevent submission to the journal. For further information see our Online Licensing, Copyright and Permissions policies. If accepted, the authors are required to update the status of any preprint, including your published paper’s DOI, as described on our Author Self-Archiving policy page.

You may self-archive versions of your work on your own webpages, on institutional webpages, and in other repositories. If you want more information about the reuse rights you retain if you publish with us, please visit our Author Self Archiving Policy page.

Conflict of Interest

When submitting a paper, you and your co-authors must declare any potential conflicts of interest. You must do this by providing the relevant details on our online submission site and by including a Conflict of Interest statement in your submitted manuscript. You can find a detailed definition of conflicts of interest under the Conflict of interest section.

Experimental Ethics

Authors must ensure that research reported in submitted manuscripts has been conducted in an ethical and responsible manner, in full compliance with all relevant codes of experimentation and legislation. All manuscripts which report in vivo experiments or clinical trials on humans or animals must include a written Statement in the Methods section that such work was conducted with the formal approval of the local human subject or animal care committees (including the name of the committee and approval number), and that clinical trials have been registered as legislation requires. In order to be published in Bioscience, Biotechnology, and Biochemistry, all clinical trials must have been registered in a public repository at the beginning of the research process (prior to patient enrollment).
Authors must confirm that any patient, service user, or participant (or that person’s parent or legal guardian) in any research, experiment or clinical trial who is described in the manuscript has given written consent to the inclusion of material pertaining to themselves, and that they acknowledge that they cannot be identified via the manuscript; and that authors have anonymized them and do not identify them in any way. Where such a person is deceased, authors must warrant they have obtained the written consent of the deceased person’s family or estate.
Authors must confirm that all mandatory laboratory health and safety procedures have been complied with in the course of conducting any experimental work reported in the manuscript; and that the manuscript contains all appropriate warnings concerning any specific and particular hazards that may be involved in carrying out experiments or procedures described in the manuscript or involved in instructions, materials, or formulae in the manuscript; and include explicitly relevant safety precautions; and cite, and if an accepted standard or code of practice is relevant, a reference to the relevant standard or code. Authors working in animal science may find it useful to consult the Guidelines for the Treatment of Animals in Behavioural Research and Teaching .

Please see this page for full details of Oxford University Press’s editorial policies .

Bioscience, Biotechnology, and Biochemistry will consider your manuscript as long as

it is your own original work and does not duplicate any previously published work, including your own;
it is not under consideration, in peer review, or accepted for publication in any journal other than Bioscience, Biotechnology, and Biochemistry;
it has not been published in any other journal; and
it contains nothing abusive, defamatory, libelous, obscene, fraudulent, or illegal.

Authors should observe high ethical standards and obey publication best practices. The following are all unacceptable:

data falsification or fabrication
plagiarism, including duplicate publication of your own work without proper citation
misappropriation of work

We treat any case of ethical or publication malpractice very seriously. We will address them in accordance with the Committee on Publication Ethics (COPE) guidelines.

Further information about ethical policies is available .

How to Submit

You must submit your paper via our web-based submission system, which may be found in the submission system . If you have not published with Bioscience, Biotechnology, and Biochemistry before, you will need to create an account. For more information, please click manuscripts support . Questions about submitting can be sent to the editorial office at [email protected] .

Article Types

Bioscience, Biotechnology, and Biochemistry publishes three different article types: Regular Papers, Notes, and Reviews. Most articles should be submitted as Regular Papers. Notes are concise but complete papers that present novel information, a new experimental method, or something similar, which might not be suitable for publication as a Regular Paper. The authors should give their reason for submitting their study as a Note in their cover letter. Articles that do not meet the criteria for a Note may be returned to authors without first going out to peer review. A Review should be on a topic of any subject that is within the scope of the journal. The publication of Reviews is by invitation only; potential authors of Reviews are contacted by one of the Editors. The submitted manuscripts will be reviewed by an Editor and reviewers.

The standard order and naming of sections for regular papers is as follows:

Introduction (no heading required); Materials and methods; Results; Discussion (Results and Discussion may be combined into one section); Conclusion (optional)

For Organic Chemistry papers only, the following order is also accepted:

Introduction (no heading required); Results; Discussion (Results and Discussion may be combined into one section); Conclusion (optional); Experimental

Ethical statements should be included in the materials and methods section if the work reports in vivo experiments or clinical trials on humans or animals (see Experimental Ethics section for details). Notes should not have sections and Reviews should have headings as deemed necessary by the authors.

Regular papers and Reviews require a graphical abstract, however graphical abstracts are not required for Notes. The graphical abstract should clearly summarize the focus and findings of the article, and will be published as part of the article online and in PDF. They should have captions of up to 150 characters in length. The graphical abstract should be submitted for peer review as a separate file, selecting the appropriate file-type designation in the journal’s online submission system. The file should be clearly named, e.g. graphical_abstract.tiff. Please see Preparing and submitting your manuscript for general guidance on appropriate file format and resolution for graphics, including figures, videos and 3D images.

Regular Papers

abstract—maximum word count: 150
graphical abstract—required
keywords—each manuscript should have 3 to 5 keywords
abstract—maximum word count: 60
graphical abstract—not required
tables and figures—maximum total number of items: 3

Notes should not exceed 3 pages when typeset, including tables, references, captions, footnotes and endnotes. Manuscripts that greatly exceed this will be critically reviewed with respect to length. Authors should include a word count with their manuscript. One page would roughly consist of 1,120 words without figures and tables. Make sure to consider the size of the figure and table when counting the words.

Reviews are published by invitation only. Instructions for review authors will be provided by the editorial office.

Minireviews

Minireviews should be concise, critical and timely articles which summarize and evaluate recent trends and/ or findings in a specific research field within the scope of the journal, and which highlight possible future directions for research in that field. As such, they should be no longer than 3,000 words, with a maximum of ３ figures/tables and 70 references.

Minireviews are published by invitation only.

main text— maximum word count: 3,000
figures/tables—maximum of 3
references—maximum of 70

Third-Party Permissions

If you wish to reproduce any material for which you do not own the copyright—including quotations, tables, or images—you must obtain permission from the copyright holder. The permissions agreement must include the following documents:

nonexclusive rights to reproduce the material in your article in Bioscience, Biotechnology, and Biochemistry
both print and electronic rights, preferably for use in any form or medium
lifetime rights to use the material
worldwide English-language rights

Further information on obtaining permissions is available .

Manuscript Preparation: Format, Structure, and Style

For new submissions of regular papers, authors may submit papers in any journal format and style..

Manuscripts should, however, still contain the basic elements comprising an appropriate title, author list, abstract, main document and references. The main document should include the standard elements of a research article, including a description of the experimental methods and materials used, a discussion of the findings, and a conclusion. Please also make sure to include an ethics statement in the materials and methods section if the work reports in vivo experiments or clinical trials on humans or animals. Whichever reference style the author uses must be consistent throughout the manuscript. Please note, however, that papers being resubmitted after revision are still required to be carefully prepared according to the formatting guidelines set out as follows.

Manuscripts should be compiled in the following order: title page; abstract; keywords; main text; acknowledgments; references; appendices (as appropriate); table(s) with caption(s) (on individual pages); figure caption(s) (as a list). Section headings should be concise. These should generally be unnumbered, however, section headings should be numbered in Review articles. Ethical statements should be included in the materials and methods section if the work reports in vivo experiments or clinical trials on humans or animals (see Experimental Ethics section for details). Data availability statements should be included in the end matter of your article under the heading ‘Data availability’ (see Data Availability Statement section for details).

For the main body of the article the journal follows the AMA style. Please refer to these requirements when preparing your manuscript. More information is available in the style guide . US spelling should be used throughout, except in quotations and in references.

Please include the following:

the title of your paper
all author names and affiliations
mailing address and email address of one corresponding author
a short running head of 50 characters or less

Abstracts have a maximum length of 150 words (60 words for Notes) and must not contain reference citations or abbreviations.

As of Vol. 85 (2021), the journal uses Harvard style (author-date) for references. Please see examples below. The BBB Endnote style can be downloaded . Authors are responsible for the accuracy of reference information.

(In text citation)

The data were identical to those in previous reports (Tatsuzawa et al. 2005; Yoshida et al. 2008).

(Reference list)

Journal article published in issue:

Tatsuzawa F, Mikanagi Y, Saito N et al. Cyanidin glycosides in flowers of genus Corydalis (Fumariaceae). Biochem Syst Ecol 2005;33:789–98.

Journal article published online:

Kennedy T, Jones R. Effect of obesity on esophageal transit. Am J Surg 1985, DOI: 10.1093/amj/amj100.

Book:

Long HC, Blatt MA, Higgins MC et al. Medical Decision Making. Boston: Butterworth-Heinemann, 1997.

Chapter in book:

Manners T, Jones R, Riley M. Relationship of overweight to haitus hernia and reflux oesophagitis. In: Newman W (ed). The Obesity Conundrum. Amsterdam: Elsevier Science, 1997, 352-74.

Website:

Public Health Laboratory Service. Antimicrobial Resistance in 2000: England and Wales. http://www.hpa.org.uk./infections/topics_az/antimicrobial_resistance/amr.pdf (7 January 2004, date last accessed).

Abbreviations

Please define nonstandard abbreviations at the first occurrence.

You must number all tables (e.g., table 1, table 2, table 3) and reference them in the text. Tables should be included at the end of the main document with captions on separate pages.

Author’s Contribution

All Regular Papers and Notes with two or more authors must contain an Author’s Contribution section briefly stating the roles and contribution of each listed author. Author’s Contribution sections are not required for Review papers.

Acknowledgments and Funding

Acknowledgments and funding information should be included at the end of your manuscript. Please fully cite any relevant funding information, including specific grant numbers.

For single agency grants: "This work was supported by the [Funding Agency] under Grant [number xxxx]."

For multiple agency grants: "This work was supported by the [Funding Agency 1] under Grant [number xxxx]; [Funding Agency 2] under Grant [number xxxx]; and [Funding Agency 3] under Grant [number xxxx]."

Information on LaTeX files and formatting is available .

You must include figure titles and legends within the manuscript file—they should not be included in the image file.

You must submit each figure as an individual image file. Submit all panels of a multipanel figure on a single page as one file. For example, if the figure has 3 panels, the figure should be submitted as one file. For composite figures with 2 or more panels, lowercase letters (a, b, c, d, etc) should be used to label the parts of the figure in the upper left corner of each panel. The figure legend should refer to each of the figure components and the letter designators in a clear and consistent format.

Images of photographs or paintings can be provided as raster images. Common examples of raster images are .tif/.tiff, .raw, .gif, and .bmp file types. The resolution of raster files is measured by the number of dots or pixels in a given area, referred to as “dpi” or “ppi.”

minimum resolution required for printed images or pictures: 350dpi
minimum resolution for printed line art: 600dpi (complex or finely drawn line art should be 1200dpi)
minimum resolution for electronic images (i.e., for on-screen viewing): 72dpi

Images of maps, charts, graphs, and diagrams are best rendered digitally as geometric forms called vector graphics. Common file types are .eps, .ai, and .pdf. Vector images use mathematical relationships between points and the lines connecting them to describe an image. These file types do not use pixels; therefore resolution does not apply to vector images.

Figures prepared as .doc/.docx or .jpeg/.jpg files will not be accepted.

Figure accessibility and alt text

Incorporating alt text (alternative text) when submitting your paper helps to foster inclusivity and accessibility. Good alt text ensures that individuals with visual impairments or those using screen readers can comprehend the content and context of your figures. The aim of alt text is to provide concise and informative descriptions of your figure so that all readers have access to the same level of information and understanding, and that all can engage with and benefit from the visual elements integral to scholarly content. Including alt text demonstrates a commitment to accessibility and enhances the overall impact and reach of your work. 

Alt-text is applicable to all images, figures, illustrations, photographs, and it isn’t required for tables and large datasets (unless the tables are provided as figures).

Alt-text is only accessible via e-reader and so it won’t appear as part of the typeset article.

Detailed guidance on how to draft and submit alt text .

Supplementary Material

You must submit supplementary data or supplementary material at the same time as the main manuscript.

Supplementary material must be cited in the text of the main manuscript.
Supplementary material will be available online only and will not be copyedited.
Style and formatting of supplementary material should be consistent with that of the manuscript.
Supplementary material should be formatted to function on any internet browser.
Supplementary material files should be no larger than 2MB each.

Presubmission Language Editing

If you are not confident in the quality of your English, you may wish to use a language-editing service to ensure that editors and reviewers understand your paper. Oxford University Press partners with Enago, a leading provider of author services. Prospective authors are entitled to a discount of 30% for editing services at Enago, via the Specialist English Editing Services for Oxford University Press Authors page.

Enago is an independent service provider, who will handle all aspects of this service, including payment. As an author you are under no obligation to take up this offer. Language editing is optional and does not guarantee that your manuscript will be accepted. Edited manuscripts will still undergo peer review by the journal.

Manuscript Charges

Author portal.

You are required to arrange payment of any open access and page charges on the same Author Portal you use to sign your licence to publish. You may refer the charges to an institutional prepayment account. Any applicable discounts will be applied prior to payment.

Page Charges

Page charges apply to Regular Papers and Notes. JSBBA members are entitled to a discount on page charges. The per-page rates are as follows:

Regular Papers (members): $42

Regular Papers (non-members): $84

Notes (members): $84

Notes (non-members): $168

OA Licence Charges

Bioscience, Biotechnology and Biochemistry offers the option of publishing under either a standard licence or an open access licence. Please note that some funders require open access publication as a condition of funding. If you are unsure whether you are required to publish open access, please do clarify any such requirements with your funder or institution.

Should you wish to publish your article open access, you should select your choice of open access licence in our online system after your article has been accepted for publication. You will need to pay an open access charge to publish under an open access licence. Note that page charges do not apply for authors who select to pay for Open Access publication.

Details of the open access licences and open access charges .

OUP has a growing number of Read and Publish agreements with institutions and consortia which provide funding for open access publishing. This means authors from participating institutions can publish open access, and the institution may pay the charge. Find out if your institution is participating .

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Fees and funding

Article-processing charges.

The publication costs for Journal of Biomedical Science are covered by the National Science and Technology Council (NSTC), Taiwan , so authors do not need to pay an article-processing charge for each article accepted for publication.

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Annual Journal Metrics

Citation Impact 2023 Journal Impact Factor: 9.0 5-year Journal Impact Factor: 10.7 Source Normalized Impact per Paper (SNIP): 2.014 SCImago Journal Rank (SJR): 2.606

Speed 2023 Submission to first editorial decision (median days): 14 Submission to acceptance (median days): 107

Usage 2023 Downloads: 1,698,723 Altmetric mentions: 3,813

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Journal of Biomedical Science

ISSN: 1423-0127

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• Plagiarism and Ethics Statement • Ethical Issues • Peer Review Policy • Policy of Conflict of Interest • Data sharing policy • Research Ethics Policy • Archiving and Repository Policy • Informed Consent Policy

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• Instruction to Authors • Manuscript Template • Checklist for Authors • Online Submission • Article Processing Charges • Waiver Policy

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Fees and funding

Article processing charges (apc).

Authors who publish open access in Cell & Bioscience are required to pay an article processing charge (APC). The APC price will be determined from the date on which the article is accepted for publication.

The current APC, subject to VAT or local taxes where applicable, is: £2190.00/$2990.00/€2590.00

Visit our open access support portal and our Journal Pricing FAQs for further information.

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Visit Springer Nature’s open access funding & support services for information about research funders and institutions that provide funding for APCs.

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Annual Journal Metrics

Citation Impact 2023 Journal Impact Factor: 6.1 5-year Journal Impact Factor: 7.0 Source Normalized Impact per Paper (SNIP): 1.129 SCImago Journal Rank (SJR): 1.836

Speed 2023 Submission to first editorial decision (median days): 20 Submission to acceptance (median days): 121

Usage 2023 Downloads: 1,490,056 Altmetric mentions: 1,979

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Cell & Bioscience

ISSN: 2045-3701

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General enquiries: [email protected]

Journal of Biosciences

Published by the Indian Academy of Sciences

Covers all areas of biology.
Founded in 1934, it has an established history in scientific publication.
Indexed in Current Contents and other standard Biological and Medical databases.
Evolved from Proceedings of the Indian Academy of Sciences (Section B), merging with Proceedings-Animal Sciences and Proceedings-Plant Sciences in 1991."

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Peiter E, Fischer M, Sidaway K, et al . 2005a Multiple RNA surveillance pathways limit aberrant expression of iron uptake mRNAs and prevent Iron toxicity in S. cerevisiae. Mol. Cell 19 39–51

Ramanna MS and Hermsen JH 1979 Genome relationships in tuber-bearing Solanums; in Biology and taxonomy of Solanaceae 3rd edition (Eds) JG Hawkes, RN Lester and AG Skelding (London: Academic Press) pp 647–654

Samiwala EB 1987 DNA cloning in Haemophilus influenzae , PhD thesis, University of Bombay, Mumbai

Zar JH 1974 Biostatistical analysis (New Jersey: Prentice Hall)

Mungi HV, Ghushe PV, Sunder AV, et al . 2015 A probiotic composition comprising the novel isolated bacterial strain of Brevibacterium casei . AP09 World Intellectual Property Organization Patent No. WO2015025336A2

Milliken W 2017 Mobilising Richard Spruce’s 19th century Amazon legacy; Kew blogs (https://www.kew.org/readand-watch/mobilising-richard-spruce-legacy)

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Introduction
Conclusions
Article Information

AE, adverse event; LTFU, lost to follow-up.

A, Proportion of patients with at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75; primary end point). B, Proportion of patients with at least a 90% improvement in the PASI score (PASI 90). C, Proportion of patients with a 100% improvement in the PASI score (PASI 100). D, Percentages of patients with a Physician’s Global Assessment (PGA) score of 0 or 1 (on a scale from 0 to 4, with higher scores indicating greater disease severity). Patients with missing values at each point and patients with assessments collected on the day of, or after the start of, a prohibited medication that was considered a major protocol deviation were imputed as nonresponders.

Trial protocol

Statistical analysis plan

eAppendix. List of Investigators

eFigure 1. Design of Phase 2b Study of Zasocitinib in Patients With Moderate-to-Severe Plaque Psoriasis

eFigure 2. Change from Baseline in DLQI in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 3. Change from Baseline in BSA Affected by Psoriasis in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 4. Time Course of PASI 50 Response Rates In Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 5. Change from Baseline in PASI in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 6. Percent Change from Baseline in PASI in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 7. Change from Baseline in PGA in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 8. Proportion of Patients Achieving a ≥2-Grade Decrease from Baseline in PGA at Weeks 2, 4, 8, and 12 in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 9. Change from Baseline in Pruritus NRS in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 10. Proportion of Patients with a Baseline Pruritus NRS Score of ≥4 Achieving a ≥4-Point Decrease from Baseline at Weeks 2, 4, 8, and 12 in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study of Zasocitinib (mITT Analysis Set)

eFigure 11. Change from Baseline in Pain NRS Among Patients with Concomitant Psoriatic Arthritis, in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study for Zasocitinib (mITT Analysis Set)

eFigure 12. Time Course of Affected BSA ≤1% Response in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study for Zasocitinib (mITT Analysis Set)

eFigure 13. Change from Baseline in Hematologic Parameters and Creatine Kinase in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study for Zasocitinib (Safety Analysis Set)

eFigure 14. Change from Baseline in Hepatic and Renal Parameters in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study for Zasocitinib (Safety Analysis Set)

eFigure 15. Change from Baseline in Lipid Parameters in Patients With Moderate-to-Severe Psoriasis in a Phase 2b Study for Zasocitinib (Safety Analysis Set)

eTable 1. Proportion of Patients With Moderate-to-Severe Psoriasis Receiving Zasocitinib Who Achieved PASI 75, 90, and 100 Responses at Weeks 2, 4, 8, and 12 (mITT Analysis Set)

eTable 2. Proportion of Patients With Moderate-to-Severe Psoriasis Receiving Zasocitinib Who Achieved a DLQI of 0 or 1 at Weeks 4, 8, and 12 (mITT Analysis Set)

eTable 3. Protocol Amendments for Phase 2b Study of Zasocitinib in Patients With Moderate-to-Severe Psoriasis

eTable 4. Summary of TEAEs by system organ class and preferred term, all periods (safety analysis set)

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Armstrong AW , Gooderham M , Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis : A Randomized Clinical Trial . JAMA Dermatol. Published online August 21, 2024. doi:10.1001/jamadermatol.2024.2701

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Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis : A Randomized Clinical Trial

1 University of California, Los Angeles
2 SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada
3 Lynde Institute for Dermatology and Probity Medical Research, Markham, Ontario, Canada
4 Innovaderm Research, Montreal, Quebec, Canada
5 ForCare Medical Center, Tampa, Florida
6 George Washington University School of Medicine, Rockville, Maryland
7 First OC Dermatology Research, Fountain Valley, California
8 Nimbus Discovery Inc, Boston, Massachusetts
9 Takeda Development Center Americas Inc, Cambridge, Massachusetts
10 Alliance Clinical Trials and Probity Medical Research, Waterloo, Ontario, Canada
11 Department of Dermatology, University of Toronto School of Medicine, Toronto, Ontario, Canada

Question Is zasocitinib effective and sufficiently safe for treating psoriasis?

Findings In this randomized clinical trial of 259 patients with moderate to severe plaque psoriasis, 18%, 44%, 68%, and 67% of patients receiving oral zasocitinib, 2 mg; zasocitinib, 5 mg; zasocitinib, 15 mg; and zasocitinib, 30 mg, respectively, achieved a 75% or greater improvement in Psoriasis Area and Severity Index scores from baseline to week 12 vs 6% of patients receiving placebo (significant at ≥5 mg). Treatment-emergent adverse events were reported for 53% to 62% of zasocitinib-treated and 44% of placebo-treated patients, with no dose dependency.

Meaning The results of this trial suggest that zasocitinib, a selective tyrosine kinase 2 inhibitor, represents a potential new oral treatment for psoriasis.

Importance New, effective, and well-tolerated oral therapies are needed for treating psoriasis. Zasocitinib, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, is a potential new oral treatment for this disease.

Objective To assess the efficacy, safety, and tolerability of zasocitinib in patients with moderate to severe plaque psoriasis.

Design, Setting, and Participants This phase 2b, randomized, double-blind, placebo-controlled, multiple-dose randomized clinical trial was conducted from August 11, 2021, to September 12, 2022, at 47 centers in the US and 8 in Canada. The study included a 12-week treatment period and a 4-week follow-up period. Key eligibility criteria for participants included age 18 to 70 years; a Psoriasis Area and Severity Index (PASI) score of 12 or greater; a Physician’s Global Assessment score of 3 or greater; and a body surface area covered by plaque psoriasis of 10% or greater. Of 287 patients randomized, 259 (90.2%) received at least 1 dose of study treatment.

Intervention Patients were randomly assigned (1:1:1:1:1) to receive zasocitinib at 2, 5, 15, or 30 mg or placebo orally, once daily, for 12 weeks.

Main Outcomes and Measures The primary efficacy end point was the proportion of patients achieving 75% or greater improvement in PASI score (PASI 75) at week 12. Secondary efficacy end points included PASI 90 and 100 responses. Safety was also assessed.

Results In total, 259 patients were randomized and received treatment (mean [SD] age, 47 [13] years; 82 women [32%]). At week 12, PASI 75 was achieved for 9 (18%), 23 (44%), 36 (68%), and 35 (67%) patients receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and 3 patients (6%) receiving placebo. PASI 90 responses were consistent with PASI 75. PASI 100 demonstrated a dose response at all doses, with 17 patients (33%) achieving PASI 100 with zasocitinib, 30 mg. Treatment-emergent adverse events occurred for 23 patients (44%) receiving placebo and 28 (53%) to 31 (62%) patients receiving the 4 different doses of zasocitinib, with no dose dependency and no clinically meaningful longitudinal differences in laboratory parameters.

Conclusions and Relevance This randomized clinical trial found that potent and selective inhibition of TYK2 with zasocitinib at oral doses of 5 mg or more once daily resulted in greater skin clearance than placebo over 12 weeks.

Trial Registration ClinicalTrials.gov Identifier: NCT04999839

Psoriasis is a chronic immune-mediated inflammatory skin disease that is associated with several comorbidities and impairs the health-related quality of life (HRQoL) of patients. 1 , 2 Approximately 20% of patients with psoriasis have 10% or more of their body surface affected. 3 Plaque psoriasis is the most common form and is characterized by erythematous, indurated plaques with overlying silvery scale.

The interleukin (IL)–23/T helper (Th)–17 axis plays a pivotal role in the pathogenesis of plaque psoriasis, 4 as evidenced by the effectiveness of injectable biologics that block IL-23 or IL-17 in its treatment. 5 However, to our knowledge, fewer oral therapies have been investigated for treating psoriasis, and none have shown the same levels of efficacy, safety, and tolerability as current biologics. 5 The paucity of oral therapies for psoriasis underscores the need for new, effective, and well-tolerated oral agents.

A promising target for novel oral agents in treating psoriasis and other immune-mediated diseases is tyrosine kinase 2 (TYK2), a Janus kinase (JAK)–related mediator involved in intracellular signaling transduction via the JAK–signal transducer and activator of transcription pathway. 6 Genome-wide association studies have shown that loss-of-function TYK2 variants may protect against several inflammatory diseases, including psoriasis. 7 - 12 Although broadly acting oral JAK inhibitors have shown efficacy in psoriasis, atopic dermatitis, alopecia areata, and vitiligo, 13 - 16 their broad inhibitory effects on multiple JAK enzymes are associated with rare but serious safety concerns, including cancers, major adverse cardiovascular events (MACEs), and infections, 17 , 18 which have limited their use and further development in psoriasis.

Deucravacitinib, an oral allosteric TYK2 inhibitor recently approved by the US Food and Drug Administration for treating moderate to severe psoriasis, has set the clinical precedent for selectively targeting TYK2 activity in this disease. 19 - 21 In contrast to JAK1-3 inhibitors, long-term follow-up has shown that deucravacitinib is not associated with an increased risk of serious safety concerns, and efficacy has been maintained for patients experiencing an early response. 22 , 23

Zasocitinib (formerly TAK-279) is an oral, allosteric inhibitor of TYK2 that binds to the Janus homology 2 (JH2) pseudokinase domain of TYK2, leading to inhibition of kinase activity and subsequent downstream signaling events. 24 Although identical in mechanism of action to deucravacitinib, zasocitinib was identified via a computationally enabled design strategy and demonstrates a higher level of selectivity than deucravacitinib for the JH2 domain of TYK2 compared with those of JAK1 and JAK2 owing to steric occlusion from the latter via a methocyclobutyl ring. 24 A previous phase 1 study demonstrated that zasocitinib modulates psoriasis primarily through its effects on the IL-23/Th-17 axis, with a safety profile consistent with TYK2 inhibition. 25 In the present phase 2b randomized clinical trial, we assessed the efficacy, safety, and tolerability of zasocitinib at various doses in patients with moderate to severe psoriasis.

This trial was conducted from August 11, 2021, to September 12, 2022. This study was conducted according to the Declaration of Helsinki, International Conference on Harmonization Good Clinical Practice recommendations, and all applicable regulations. The study protocol (and amendments; Supplement 1 and Supplement 2 ) and informed consent forms were reviewed and approved by an institutional review board and the central ethics committee of Advarra. All participants agreed to participate in the study by providing their written informed consent form. Consolidated Standards of Reporting Trials ( CONSORT ) reporting guidelines were followed during the development of this article. 26

This was a phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose trial that enrolled patients with moderate to severe psoriasis from 47 centers in the US and 8 centers in Canada. Patients were randomized 1:1:1:1:1 (stratified by previous treatment with biologics) to receive 1 of 4 oral doses of zasocitinib (2, 5, 15, or 30 mg, once daily) or matching oral placebo for 12 weeks, with an additional 4-week follow-up period for safety monitoring (eFigure 1 in Supplement 3 ). Protocol amendments are listed in eTable 3 in Supplement 3 .

Patients aged 18 to 70 years at the time of consent who had plaque psoriasis for 6 months or longer before the screening visit were eligible for inclusion if they had moderate to severe disease as defined by a Psoriasis Area and Severity Index (PASI) 27 score of 12 or greater and a Physician’s Global Assessment (PGA) score of 3 or greater at screening and day 1, plaque psoriasis covering 10% or more of their total body surface area (BSA) at screening and day 1, a body mass index (calculated as weight in kilograms divided by height in meters squared) of 18 to 42, a total body weight of more than 50 kg, no substantial flare in psoriasis for 3 months or longer before screening, and were a candidate for phototherapy or systemic therapy. Patients were excluded if they had erythrodermic, pustular, guttate, or drug-induced psoriasis; active bacterial, viral, fungal, mycobacterial, or other infections (including tuberculosis); or active herpes infection (including herpes simplex 1 and 2 and herpes zoster) within 8 weeks before the baseline (study day 1), as well as positive results for hepatitis B, hepatitis C, or HIV; a previous lack of response to any therapeutic agent targeting IL-12/IL-23, IL-17, and/or IL-23; or any use of topical or systemic treatment that could have affected psoriasis within 2 and 4 weeks before baseline, respectively. Full inclusion and exclusion criteria are available in Supplement 1 .

Patients were randomized using a randomization list generated using validated software (SAS, version 9.4; SAS Institute) that was stratified based on previous treatment with biologics (yes/no) and kept secured until the masking was broken at the end of study. During screening, investigators acquired a patient identifier number via an interactive web response system, and a randomization number was allocated to each patient. This number contained the site number and patient number and was assigned in numerical order at the screening visit based on a chronological order of screening dates. Participants, investigators, study staff, the company research organization, or the sponsor’s study team were masked to treatment and randomization information.

The primary efficacy end point was the proportion of patients achieving 75% or greater improvement in PASI score from baseline (PASI 75) at week 12. Secondary efficacy end points included the proportion of patients achieving a PASI 90 or 100 response, or a PGA score of clear (0) or almost clear (1), and change from baseline in the Dermatology Life Quality Index (DLQI) at week 12. 28 Exploratory efficacy end points are described in the eMethods in Supplement 3 . Safety end points included the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) and changes in vital signs, clinical laboratory parameters, and electrocardiograms.

A sample size of 250 patients (approximately 50 patients per treatment group) was determined to provide 85% power to detect a PASI 75 (≥75% improvement from baseline) response rate of 40% or greater in at least 1 of the zasocitinib treatment groups at a significance level of α = .05 using a 2-sided test, assuming a placebo response rate of 10%. Patient demographic and baseline disease characteristics were summarized using descriptive statistics (frequency and percentage). Race was determined according to what the patient felt best described them. Analyses of patient demographic characteristics, baseline disease characteristics, and the primary and secondary efficacy end points were conducted on the modified intent-to-treat analysis set (all randomized patients who received ≥1 dose of the study treatment). Analysis of the safety end points was conducted in the safety analysis set (all patients who received ≥1 dose of the study treatment). Nonresponse was imputed for missing data for binary end points. Multiplicity adjustment in the primary end point analysis used a hierarchical testing procedure, starting with the highest dose and ending with the lowest dose. No adjustments for multiple comparisons for secondary end points were made; as such, P values for secondary end points are not reported. Point estimates with unadjusted confidence intervals are reported. All analyses were conducted using SAS (version 9.4 or higher; SAS Institute).

PASI 75, 90, and 100 responses and achievement of a PGA score of 0 or 1 were assessed using descriptive statistics by visit for each group. Longitudinal line plots for PASI 75, 90, and 100 responses and achievement of a PGA score of 0 or 1 by treatment group were also created.

A Cochran-Mantel-Haenszel test (using previous biologic treatment as a stratification factor) was used to compare the proportion of patients achieving PASI 75, 90, and 100 scores and PGA 0/1 responses between each active treatment group and placebo. Change from baseline in DLQI was analyzed using a mixed model for repeated measures method. The model included treatment group, visit (weeks 4, 8, and 12), treatment-by-visit interaction, and previous treatment, with biologics as fixed effects and baseline score as a covariate.

In total, 443 patients were screened for eligibility, of whom 287 (65%) were randomly allocated to 1 of the 4 active treatment groups or placebo, and 259 (58%) received at least 1 dose of study treatment. Overall, 36 patients (14%) discontinued the study prematurely, with 223 (86%) completing the 12-week treatment period ( Figure 1 ). Discontinuations due to TEAEs were infrequent and comparable across treatment groups.

Patient demographic and baseline disease characteristics were consistent with moderate to severe plaque psoriasis clinical trial populations and were comparable across treatment groups ( Table 1 ). The patient population was predominantly White (215 [83%]) and male (177 [68%]), with a mean (SD) age of 47 (13) years. Approximately 41 patients (16%) had received previous treatment with biologics. The median (range) duration of psoriasis was 12 (6-22) years, mean (SD) PASI score was 18 (6), and mean (SD) BSA was 22% (13%).

At week 12, the primary efficacy end point (PASI 75) was achieved in patients receiving zasocitinib at doses of 5 mg and higher: 9 (18%), 23 (44%), 36 (68%), and 35 (67%) patients in the zasocitinib 2-, 5-, 15-, and 30-mg groups, respectively, and in 3 patients (6%) in the placebo group. PASI 75 responses increased from 2 mg to 15 mg but were similar at 15 mg and 30 mg ( Table 2 ).

PASI 90 was achieved for 4 (8%), 11 (21%), 24 (45%), and 24 patients (46%) receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and for no patients in the placebo group. The pattern of the dose-response association for PASI 90 was similar to PASI 75 ( Table 2 ). PASI 100 was achieved for 1 (2%), 5 (10%), 8 (15%), and 17 (33%) patients receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and for no patients in the placebo group. An increase in PASI 100 was observed across all doses tested, with the highest response in the 30-mg group ( Table 2 ). The effects of zasocitinib treatment on PASI responses were also apparent as early as week 4 and persisted through to the end of the 12-week treatment period ( Figure 2 , A-C; eTable 1 in Supplement 3 ).

A PGA score of 0 or 1 was achieved at week 12 for 5 (10%), 14 (27%), 26 (49%), and 27 (52%) patients receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and for 2 patients (4%) in the placebo group ( Table 2 ). As with PASI 75 and PASI 90, the proportion of patients achieving a PGA score of 0 or 1 at week 12 increased between the 2-mg and 15-mg doses of zasocitinib, with similar efficacy observed with the 15-mg and 30-mg doses ( Figure 2 D). In a post hoc analysis, a PGA score of 0 (clear skin) was achieved for 1 of 50 (2%), 5 of 52 (10%), 8 of 53 (15%), and 17 of 52 (33%) patients receiving zasocitinib at 2, 5, 15, and 30 mg, respectively, and for no patients in the placebo group.

No difference in DLQI score was observed at any visit for patients receiving zasocitinib, 2 mg, compared with placebo and only at week 8 and beyond for zasocitinib, 5 mg. Greater changes from baseline were observed in patients receiving zasocitinib at 15 mg, and 30 mg compared with placebo, which were observed at week 4 and maintained through week 12 (eFigure 2 in Supplement 3 ). Changes from baseline in affected BSA generally mirrored the findings for the primary and secondary end points (eFigure 3 in Supplement 3 ). The findings for other exploratory efficacy outcomes are presented in the eResults in Supplement 3 .

TEAEs occurred at a higher rate in the zasocitinib treatment groups (53%-62%) compared with placebo (44%); however, there was no dose-response association for any specific TEAE ( Table 3 ). COVID-19, acne/acneiform dermatitis, and diarrhea were the most frequently reported events (reported by 3 or more patients in any treatment group) ( Table 3 ). TEAEs leading to study treatment discontinuation occurred for 1 to 2 patients (2%-4%) in the zasocitinib treatment groups and 1 patient (2%) in the placebo group. Two SAEs were reported in a single patient receiving zasocitinib, 15 mg (severe pleural effusion and severe pericardial effusion); however, these were considered unrelated to study drug ( Table 3 ). There were no MACE, thromboembolic events, or opportunistic infections.

No clinically meaningful longitudinal differences were observed in laboratory parameters for cholesterol levels, blood cell counts, liver enzyme levels, or estimated glomerular filtration rates with zasocitinib compared with placebo. Creatine kinase elevations were more common in the zasocitinib treatment groups compared with placebo, but there was no evidence of dose dependence (eFigures 13-15 in Supplement 3 ). Clinically significant TEAEs associated with creatine kinase elevation were observed at similar rates between the zasocitinib treatment groups and placebo, and there were no cases of rhabdomyolysis. A full list of all TEAEs is contained in eTable 4 in Supplement 3 .

In this randomized clinical trial, the primary end point of PASI 75 response at week 12 was achieved for patients receiving zasocitinib at doses of 5 mg and higher. The secondary end points of PASI 90 and 100 and a PGA score of 0 or 1 were concordant with the primary end point. A trend for a dose-response association was observed for PASI 75 and 90 up to zasocitinib, 15 mg, with similar efficacy achieved with zasocitinib, 30 mg. By contrast, the trend for a dose-response association for PASI 100 continued past zasocitinib, 15 mg, with the highest response with zasocitinib, 30 mg. This suggests that higher coverage of the target is more likely to result in complete skin clearance without the risk of clinically significant toxic effects characteristic of JAK1-3 inhibition.

The current study also investigated the effect of zasocitinib on the HRQoL of patients using the DLQI. Previous studies using DLQI and the Psoriasis Symptom Inventory have shown that complete skin clearance (PASI 100) is associated with clinically meaningful improvements in the HRQoL and psoriasis symptoms of patients compared with almost complete skin clearance (PASI 90 to <100). 29 - 32 In the current study, patients receiving zasocitinib, 30 mg, had the greatest reduction in DLQI from baseline compared with all other zasocitinib treatment groups and placebo, indicating a dose-responsive improvement in HRQoL. Greater DLQI reductions from baseline in the zasocitinib, 15 mg, and zasocitinib, 30 mg, treatment groups relative to placebo were observed from as early as week 4.

The incidence of TEAEs was higher in the zasocitinib groups compared with placebo, but there was no clear dose dependence for any individual TEAE. The incidence of TEAEs of 44% in the placebo arm aligned with previous clinical trial results of treatments in plaque psoriasis, for which TEAEs occurred at similar rates between treatment and placebo groups. 19 , 33 , 34 COVID-19, acne/acneiform dermatitis, and diarrhea were the most frequently reported TEAEs. No treatment-related SAEs or opportunistic infections or psychiatric sequelae (eg, suicide attempts) were reported during the study. In addition, rates of study discontinuation due to TEAEs were low overall and comparable between the placebo and active treatment groups. Some asymptomatic, transient, and/or reversible change in some laboratory parameters were also observed, such as creatine kinase elevation; however, these were not considered meaningful by the investigators, and there were no cases of rhabdomyolysis. Additionally, there were no dose-dependent associations between zasocitinib use and changes in liver function or hematology parameters. Consistent with the phase 3 randomized clinical trials of deucravacitinib, 20 , 21 there were no MACE or thromboembolic events observed in this trial. The efficacy and safety results from the current study were also consistent with previous studies on zasocitinib. 25 , 35

The lack of JAK-related safety signals was consistent with the high level of selectivity that zasocitinib demonstrates for the JH2 domain of TYK2 ( K D [dissociation constant] = 0.0038 nM) relative to the JH2 domains of JAK1 and JAK2 ( K D = 4975 and 23 000 nM, respectively). 24 This level of selectivity is achieved through the presence of a methoxycyclobutyl ring that fits into the binding pocket of the TYK2 JH2 domain (defined by Val603 and Lys642) but is sterically occluded from the JAK1 and JAK2 JH2 domains owing to the presence of Ile597 and Ile559 residues. 24 Such a selectivity profile could potentially elicit fewer off-target SAEs than currently available JAK1-3 inhibitors, allowing for exploration of higher doses of zasocitinib. By contrast, deucravacitinib binds with a lower binding affinity for TYK2 than that demonstrated by zasocitinib. 24 Whether these differences translate into corresponding levels of clinical efficacy remains to be confirmed in further clinical trials.

As with any phase 2 trial, this study had limitations, including a potential lack of power due to the small sample size and short study duration. In addition, less than 8% of the patient population was Black or African American, and the study was conducted at centers in North America only and involved a restricted range of patient weights and body mass indices. Therefore, these findings may not be generalizable to more diverse populations in other geographic regions.

In this randomized clinical trial, zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one-third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of JAK1-3 inhibition. Two phase 3 studies of longer duration and with larger populations ( NCT06088043 and NCT06108544 ) have been initiated to confirm these early observations.

Accepted for Publication: June 17, 2024.

Published Online: August 21, 2024. doi:10.1001/jamadermatol.2024.2701

Corresponding Author: April W. Armstrong, MD, MPH, University of California, Los Angeles (UCLA), PO Box 1155, Studio City, CA 91614 ( [email protected] ).

Author Contributions: Dr Armstrong had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Green, Zhao, Srivastava, Papp.

Acquisition, analysis, or interpretation of data: Armstrong, Gooderham, Lynde, Maari, Forman, Green, Laquer, X. Zhang, Franchimont, Gangolli, Blau, W. Zhang, Srivastava, Heap, Papp.

Drafting of the manuscript: Green, W. Zhang, Heap.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Lynde, X. Zhang, Blau, W. Zhang, Srivastava.

Administrative, technical, or material support: Armstrong, Lynde.

Supervision: Maari, Forman, Green, Laquer, Franchimont, Blau, Zhao, Heap.

Other: Gangolli.

Conflict of Interest Disclosures: Dr Armstrong reported grants from AbbVie, ASLAN, BMS, Dermavant Sciences, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Meiji Seika Pharma Co, Modernizing Medicine, Nimbus Therapeautics, Novartis, Ortho Dermatologics, Pfizer, Sanofi Genzyme, UCB, and Ventyx Biosciences; personal fees from AbbVie, ASLAN, Almirall, Amgen, Arcutis, Beiersdorf, BMS, Dermavant, EPI Health, Janssen, LEO Pharma, Mindera, Nimbus, Organon & Co, Sanofi, Sun Pharma, Takeda, Ventyx Biosciences, Incyte, Regeneron, and UCB; and data safety monitoring board service for Boehringer Ingelheim and Parexel during the conduct of the study. Dr Gooderham reported nonfinancial support from Takeda during the conduct of the study as well as personal fees from AbbVie, Amgen, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Meiji, Dermavant, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, and Apogee outside the submitted work. Dr Lynde reported being a principal investigator for AbbVie, Amgen, Akros, Arcutis, Bausch Health, Bayer, BioJAMP, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, CeraVe, Bioderma, Cipher, Concert, Dermavant, Eli Lilly, Devonian, Evelo, Galderma, GSK, InCyte, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, Leo Pharma, L’Oreal, Medexus, Merck, MoonLake, Nao, Nimbus, Novartis, P&G, PediaPharm, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sandoz, Sentrex, SunPharma, Takeda, TEVA, Tribute, UCB, Valeant, Viatris, and Volo Health during the conduct of the study as well as personal fees from AbbVie, Amgen, Aralez, Bausch Health, Bayer, Bioderma , BioJAMP, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, CeraVe, Cipher, Dermavant, Eli Lilly, Fresnius Kabi, Gakderna, GSK, InCyte, Innovaderm, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, Leo Pharma, L’Oreal, Medexus, MedX, Merck, Naos, Novartis, P&G, PediaPharm, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sandoz, Sentrex, Skinceuticals, SunPharma, Takeda, TEVA, Tribute, UCB, Valeant, Viatris, and VOLO Health outside the submitted work. Dr Maari reported a research grant from Nimbus Pharmaceutical. Dr Green reported grants from Takeda during the conduct of the study as well as grants from Amgen, Arcutis, Dermavant, BMS, Alumis, HIghlittl, Takeda, Galderma, OrthoDerm, UCB, and Janssen outside the submitted work. Dr Franchimont reported being employed by and holding equity in Nimbus during the conduct of the study as well as being a former employee of and shareholder in Biogen, holding stock and shares in and board service for OMass Therapeutics, personal fees from Bain Capital and Atara Biotherapeutics, and board service for Rome Therapeutics outside the submitted work; additionally, their spouse is an employee and shareholder of Alexion. Dr Gangolli reported employment for and stock ownership in Nimbus during the conduct of the study as well as stock ownership in Bristol Myers Squibb and AstraZeneca outside the submitted work. Dr Blau reported personal fees from Takeda Pharmaceuticals outside the submitted work. Dr Zhao reported being an employee of Takeda outside the submitted work. Dr W. Zhang reported personal fees from Takeda during the conduct of the study and outside the submitted work. Dr Srivastava reported being an employee of and shareholder in Nimbus Therapeutics during the conduct of the study and outside the submitted work. Dr Heap reported stock holdings and employment with Takeda Pharmaceuticals. Dr Papp reported committee/board service for AbbVie, Acelyrin, Akros, Alumis, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, BMS, Can-Fite Biopharma, Celltrion, Concert, Dermavant, Dermira, Dice Pharmaceuticals, Eli Lilly, Evelo Biosciences, Forbion, Galderma, Horizon Therapeutics, Incyte, Janssen, Kymab, Kyowa Hakko Kirin , Leo, Meiji Seika Pharma, Mitsubishi Pharma, Nimbus, Novartis, Pfizer, Reistone, Sanofi-Aventis, Sandoz, Sun Pharma, Takeda, Tarsus Pharmaceuticals, UCB, and Zai Lab Co during the conduct of the study. No other disclosures were reported.

Funding/Support: This study was funded by Nimbus Discovery Inc, which refers to the group of entities including Nimbus Therapeutics LLC, Nimbus Discovery Inc, and Nimbus Lakshmi, Inc. Nimbus Lakshmi Inc was acquired by Takeda Pharmaceuticals in February 2023.

Role of the Funder/Sponsor: Nimbus Discovery Inc was involved in the design of the study, provision of study drug, conduct of blinded safety monitoring, development of the analysis plan, and data collection, analysis, and interpretation. Takeda Pharmaceuticals was involved in the funding of medical writing support, review of the manuscript throughout development, and approval of the final version of the manuscript for submission.

Additional Contributions: Medical writing support, provided by Christina Nikolakopoulou, PhD, of Oxford PharmaGenesis, Oxford, UK, was funded by Takeda Development Center Americas, Inc.

Data Sharing Statement: See Supplement 4 .

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Tyrosine Kinase 2 Inhibition With Zasocitinib in Psoriasis
Key Points. Question Is zasocitinib effective and sufficiently safe for treating psoriasis?. Findings In this randomized clinical trial of 259 patients with moderate to severe plaque psoriasis, 18%, 44%, 68%, and 67% of patients receiving oral zasocitinib, 2 mg; zasocitinib, 5 mg; zasocitinib, 15 mg; and zasocitinib, 30 mg, respectively, achieved a 75% or greater improvement in Psoriasis Area ...