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.

Protagonist Therapeutics, Inc. will be eligible to receive $60 million in milestone payments in the fourth quarter for the advancement of JNJ-2113 (formerly known as PN-235) 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. 

JNJ-2113, the first and only targeted oral peptide designed to block the IL-23 receptor.

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 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," says Dinesh V. Patel, PhD, President and CEO of Protagonist, in a news release.

"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."

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.

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 Protagonist and Janssen Biotech, Inc., a Johnson & Johnson company. Protagonist completed a Phase 1 study of JNJ-2113 in healthy volunteers in October of 2021 and Johnson & Johnson retains exclusive, worldwide rights to develop in Phase 2 and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.