Protagonist Therapeutics announces advancement of JNJ-2113 across indications

Protagonist Therapeutics (PTGX) 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 (JNJ), the Company’s partner in the development of JNJ-2113. The ICONIC clinical development program in adult patients with moderate to severe psoriasis 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 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 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. Protagonist will earn a $50 million milestone payment upon dosing of the third patient in the ICONIC Phase 3 program-whichever study meets that milestone first-and a $10 million milestone payment upon dosing of the third patient in the ANTHEM-UC Phase 2b study, and remains eligible for up to an additional $795 million in other development and sales milestone payments with respect to JNJ-2113. The Company will also earn upward tiering royalties of 6%-10%, with the 10% tier applicable for net sales of greater than $4 billion.