Late-Breaking Presentation at American Academy of Dermatology 2024 Annual Meeting Shows that JNJ-2113, the First and Only Investigational Targeted Oral Peptide, Maintained Skin Clearance in Moderate-To-Severe Plaque Psoriasis Through One Year

Long-term extension (LTE) FRONTIER 2 study demonstrated sustained efficacy and similar safety results from Week 16 to Week 52, consistent with previously reported FRONTIER 1 16-week Phase 2b study

The proportion of patients achieving PASI 75, 90 and 100 response rates at Week 16 were maintained through Week 52, confirming the durability of response

59.5% and 64.3% of patients in the highest dose group (100 mg BID) achieved a PASI 90 response at Weeks 16 and 52 respectively; PASI 90 is a co-primary endpoint for multiple Phase 3 studies in the ICONIC clinical development program

No evidence of dose-dependent increase in AEs across the JNJ-2113 treatment groups

NEWARK, CA / ACCESSWIRE / March 11, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or "the Company") today announced a late-breaking presentation at the American Academy of Dermatology (AAD) 2024 Annual Meeting with positive results from the Phase 2b FRONTIER 2 long-term extension study evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor, for adult patients with moderate-to-severe plaque psoriasis (PsO). JNJ-2113 is being developed by J&J Innovative Medicine, Inc. (see today's accompanying press release from J&J), under a license and collaboration agreement with Protagonist, and is currently enrolling four pivotal Phase 3 psoriasis studies in the ICONIC clinical development program and one Phase 2b ulcerative colitis study.

FRONTIER 2 enrolled patients who completed the 16-week dose ranging FRONTIER 1 Phase 2b study and evaluated patients from Week 17 through Week 52. In FRONTIER 2, JNJ-2113 maintained high rates of skin clearance through 52 weeks in adults with moderate-to-severe plaque psoriasis, as measured by Psoriasis Area and Severity Index (PASI) response rates of 75%, 90% and 100%. Recently, results from FRONTIER 1 were published in The New England Journal of Medicine and showed superior efficacy of JNJ-2113 at all doses tested and similar safety compared to placebo at Week 16.

"The positive and consistent results from the 52-week FRONTIER 2 study demonstrate the durability of response observed in the 16-week FRONTIER 1 study and reaffirm JNJ-2113's potential as the best-in-class oral agent for psoriasis," said Dinesh V. Patel, PhD, President and CEO of Protagonist. "We continue to believe that JNJ-2113 can potentially have a transformative impact on the treatment of psoriasis and look forward to its assessment across a spectrum of other IL-23-mediated diseases, including the Phase 2b ANTHEM ulcerative colitis study."