Protagonist's Phase 2b Trial Of JNJ-2113 In Psoriasis Achieved Primary Efficacy Endpoint

(RTTNews) - Protagonist Therapeutics, Inc. (PTGX) Tuesday announced that its Phase 2b FRONTIER 1 trial of oral IL-23 receptor antagonist JNJ-2113 in patients with moderate-to-severe plaque psoriasis met the primary efficacy endpoint.

The clinical trial in collaboration with Janssen Biotech, Inc. evaluated the oral Interleukin-23 receptor antagonist peptide. The primary endpoint of the study is the proportion of patients achieving PASI-75 at 16 weeks.

The 255-patient study said a clear dose-response was observed across an eight-fold dose range. The company plans to present the pre-clinical and clinical studies on JNJ-2113 at medical conferences beginning in the second quarter of 2023.

The randomized, multicenter, double-blind, placebo-controlled study evaluated three once-daily dosages and two twice-daily dosages of JNJ-2113 taken orally.

Protagonist completed a Phase 1 study of JNJ-2113 in healthy volunteers in October of 2021 and Janssen retains exclusive, worldwide rights to develop in Phase 2 and beyond, and to commercialize compounds from the research.