Protagonist Therapeutics, Inc. announced positive topline results from its collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), in the FRONTIER 1 Phase 2b clinical trial evaluating the oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate-to-severe plaque psoriasis. Data from the 255-patient study showed that JNJ-2113 achieved the study's primary efficacy endpoint, with a statistically significant greater proportion of patients who received JNJ-2113 achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) responses compared to placebo at Week 16 in all five treatment groups. A clear dose response was observed across an eight-fold dose range.

Treatment was well tolerated, with no meaningful difference in frequency of adverse events across treatment groups versus placebo. Data will be presented from various pre-clinical and clinical studies on JNJ-2113 at medical conferences beginning in the second quarter of 2023. The FRONTIER 1 Phase 2b trial (NCT05223868) was designed to assess the efficacy and safety of JNJ-2113 in patients with moderate-to-severe plaque psoriasis.

It is a randomized, multicenter, double-blind, placebo-controlled study that evaluated three once-daily dosages and two twice-daily dosages of JNJ-2113 taken orally. The primary endpoint of the study is the proportion of patients achieving PASI-75 at 16 weeks. Beyond the recently completed Phase 2b FRONTIER 1 study and a Phase 1 trial (NCT05062200) in healthy Japanese and Chinese participants, JNJ-2113 is currently being studied in multiple trials, also led by Janssen.

FRONTIER 2 (NCT05364554) is a long-term extension study of JNJ-2113 in adults with moderate to severe plaque psoriasis; the SUMMIT Phase 2a trial (NCT05357755) is testing a delayed release JNJ-2113 tablet versus placebo in adults with moderate to severe plaque psoriasis; and a Phase 1 trial (NCT05703841) of an immediate release formulation of JNJ-2113 in healthy Chinese adult participants is currently recruiting.