Protagonist Announces Two New Phase 3 ICONIC Studies in Psoriasis Evaluating JNJ-2113 in Head-to-Head Comparisons with Deucravacitinib

The ICONIC program now includes four Phase 3 studies evaluating JNJ-2113;
Co-primary endpoints for all four studies are PASI-90 and/or IGA 0 or 1

Protagonist eligible to receive $115 million milestone upon achieving the co-primary endpoints in any one of the studies

NEWARK, CA / ACCESSWIRE / November 27, 2023 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced two additional Phase 3 studies, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, evaluating JNJ-2113 (formerly PN-235) in head-to-head comparisons against deucravacitinib, an oral TYK2 inhibitor, in patients with moderate-to-severe psoriasis. Details regarding ADVANCE 1 are available on clinicaltrials.gov. The ICONIC program now includes four Phase 3 studies: ADVANCE 1, ADVANCE 2 and as previously announced, LEAD and TOTAL. Protagonist is eligible to receive a $115 million milestone payment upon achieving the co-primary endpoints in any one of the studies.

ICONIC-ADVANCE 1 is a Phase 3 trial evaluating the safety and efficacy of JNJ-2113 compared to both placebo and deucravacitinib. The trial's co-primary endpoints are PASI-90 and IGA score of 0 or 1. The trial, which is expected to begin enrolling patients in the first quarter of 2024, is led by the Company's collaboration partner, Janssen Biotech, Inc., a Johnson & Johnson company (Janssen). ICONIC-ADVANCE 2, a similarly designed study, is expected to start enrolling patients later in 2024.

"We are very pleased with the rapid progression of the ICONIC Phase 3 psoriasis program, and in particular with the design of the ICONIC-ADVANCE trials. JNJ-2113 is the only targeted oral peptide in late-stage development that is designed to selectively block the IL-23 receptor, and we believe the ICONIC studies have the potential to establish JNJ-2113 as the preferred oral treatment option for psoriasis patients," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "The strength of the FRONTIER 1 Phase 2b data reported in July and the robust designs for the Phase 3 program give us renewed confidence that JNJ-2113 will meet all of our objectives under the terms of our partnership with Janssen."

Details regarding the two previously announced ICONIC Phase 3 psoriasis trials as well as the ANTHEM-UC Phase 2b study evaluating JNJ-2113 in ulcerative colitis, can be found at the following links on clinicaltrials.gov: ICONIC-LEAD, ICONIC-TOTAL and ANTHEM-UC. All of the clinical studies utilize the same once-daily, immediate-release formulation of JNJ-2113 as was used in the successful FRONTIER 1 Phase 2b study.