Protagonist Therapeutics, Inc. announced Phase III studies, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, for JNJ 2113 in head-to-head comparisons against deucravacitinib,- in patients with moderate-to-severe psoriasis.

Details regarding ADVANCE 1 are available on clinicaltrials.gov. The ICONIC program now includes four Phase III 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 III 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 III 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 IIb data reported in July and the robust designs for the Phase III 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 III psoriasis trials as well as the ANTHEM-UC Phase IIb study evaluating JNJ 2113 in ulcerative colitis, can be found at 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 IIb study.

JNJ 2113 is a first and only targeted oral peptide that is designed to selectively block the IL-23 receptor that was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Janssen. Protagonist completed a Phase 1 study of JNJ 2113 in 2021 and Janssen retains exclusive, worldwide rights to develop in Phase II and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement which covers a broad range of indications.