Protagonist Therapeutics Inc (NASDAQ: PTGX) announced topline results from its collaboration with Janssen Biotech Inc, a part of Johnson & Johnson (NYSE: JNJ), in the FRONTIER 1 Phase 2b trial of 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 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 the 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.
JNJ-2113 (formerly PN-235) was discovered and is being developed under the license and collaboration agreement between Protagonist and Janssen Biotech.
Protagonist completed a Phase 1 study of JNJ-2113 in healthy volunteers in October 2021.
Janssen retains exclusive, worldwide rights to develop in Phase 2 and beyond and commercialize compounds derived from the research conducted under the agreement against a broad range of indications.
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