The ICONIC clinical development program in adult patients with moderate to severe psoriasis (PsO) is advancing to Phase 3 with two studies starting in November, and the ANTHEM-UC Phase 2b study in adults with moderately to severely active ulcerative colitis (UC) will begin this month.
The three JNJ-2113 studies that are commencing this quarter include: ICONIC-LEAD - A randomized controlled Phase 3 trial to evaluate the safety and efficacy of JNJ-2113 compared with placebo in participants with moderate to severe plaque psoriasis, with PASI-90 and IGA score of 0 or 1 as co-primary endpoints; ICONIC-TOTAL - A randomized controlled Phase 3 trial to evaluate the efficacy and safety of JNJ-2113 compared with placebo for the treatment of plaque psoriasis in participants with at least moderate severity affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet) with overall IGA score of 0 or 1 as the primary end point and ANTHEM-UC - A Phase 2b randomized controlled trial to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Additional Phase 3 studies will be initiated in the first quarter of 2024 as part of the broader psoriasis ICONIC clinical program. All the studies in the ICONIC program will use the once daily, immediate release formulation from the previously completed FRONTIER 1 study.
'The robust and expanding clinical development program for JNJ-2113, the first and only targeted oral peptide designed to block the IL-23 receptor, reflects the tremendous level of commitment and confidence for this drug candidate, and its potential to have a positive impact in the lives of patients who can benefit from an oral treatment option,' said
'The success of the IL-23 receptor antagonist peptide program from de novo discovery through initiation of multiple Phase 3 studies in psoriasis and expansion into inflammatory bowel disease and other potential indications reflects the innovative power of Protagonist's peptide technology platform and the strength of a synergistic partnership between Protagonist and Janssen.'
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License and Collaboration Agreement
JNJ-2113 (formerly known as PN-235) was discovered and is being developed pursuant to the license and collaboration agreement between
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This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of JNJ-2113, our expectations regarding the clinical development of JNJ-2113, our potential receipt of milestone and royalty payments under our collaboration agreement with Janssen, our forecasted cash runway and our expectations regarding enrollment in the REVIVE Phase 3 trial. In some cases, you can identify these statements by forward-looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the
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