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Protagonist Announces Advancement of JNJ-2113 Across Multiple Indications
ICONIC Phase 3 clinical program initiation in adults with moderate to severe plaque psoriasisANTHEM Phase 2b initiation in ulcerative colitisCompany is
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"ICONIC Phase 3 clinical program initiation in adults with moderate to severe plaque psoriasisANTHEM Phase 2b initiation in ulcerative colitisCompany is eligible to receive next two milestone payments for a total of $60MNEWARK, CA / ACCESSWIRE / October 9, 2023 / Protagonist Therapeutics, Inc. (\"Protagonist\" or the \"Company\") (NASDAQ:PTGX) today announced that the company will be eligible to receive $60M in milestone payments in the fourth quarter for the advancement of JNJ-2113 into multiple clinical development programs led by Janssen Biotech, Inc., a Johnson & Johnson company (Janssen), the Company's partner in the development of JNJ-2113. 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; andANTHEM-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 l...