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Protagonist Therapeutics Announces Positive Topline Results for Phase 2b FRONTIER 1 Clinical Trial of Oral IL-23 Receptor Antagonist JNJ-2113 (PN-235) in Psoriasis
JNJ-2113 (formerly PN-235) met the study's primary endpoint, with a statistically significantly higher proportion of adult patients with moderate-to-severe
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"JNJ-2113 (formerly PN-235) met the study's primary endpoint, with a statistically significantly higher proportion of adult patients with moderate-to-severe plaque psoriasis achieving PASI-75 in all treatment groups at Week 16 compared to placebo\nTreatment was well tolerated, with no meaningful difference in frequency of adverse events across treatment groups\nNEWARK, Calif., March 7, 2023 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) (\"Protagonist\" or \"the Company\"), today 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.\nData 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.\n\"We are thrilled to be at this transformative junction, with JNJ-2113 being the first- and only-in-class oral IL-23 receptor antagonist as a potential oral targeted therapy for plaque psoriasis, further underscoring the strength of our innovative peptide technology platform. A full measure of JNJ-2113 should be evident when the FRONTIER 1 Phase 2b data are shared at an upcoming medical conference. It is our expectation that JNJ-2113 will progress into a Phase 3 registrational study in plaque psoriasis on the strength of these data. We are excited about JNJ-2113's potential prospects across the spectrum of additional IL-23 mediated diseases,\" said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist.\nDr. Patel continued, \"We see this as a watershed moment for Protagonist, the indust...