JNJ-2113 Sustains Skin Clearance in Moderate-to-Severe Psoriasis for a Year

Johnson & Johnson has reported sustained efficacy and safety of its investigational oral peptide JNJ-2113 in treating moderate-to-severe plaque psoriasis (PsO) through one year in the FRONTIER 2 study extension. The IL-23 receptor blocker demonstrated consistent response rates from week 16 to week 52, with a 76.2% Psoriasis Area and Severity Index (PASI) 75 response in the 100 mg twice-daily group. Key secondary endpoints were also upheld, with a 64.3% PASI 90 response and 40.5% achieving PASI 100. The safety profile was consistent with the FRONTIER 1 study, showing no dose-dependent increase in adverse events, including gastrointestinal disorders. Common adverse events included nasopharyngitis, upper respiratory tract infection, and COVID-19, with serious adverse events occurring in 4% of patients and deemed unrelated to the treatment.

The findings indicate JNJ-2113's potential as a durable and convenient oral therapeutic option for PsO patients. The drug's development is part of a license and collaboration agreement between Protagonist Therapeutics and Johnson & Johnson, with the latter holding exclusive rights to develop and commercialize JNJ-2113. The Phase 3 ICONIC clinical program is currently evaluating JNJ-2113's safety and efficacy in adults with moderate-to-severe plaque PsO. Additionally, the Phase 2b ANTHEM-UC study is assessing the drug's impact on ulcerative colitis, another IL-23-mediated disease.

The results from FRONTIER 1 and FRONTIER 2 support the potential of JNJ-2113 in treating a range of IL-23-mediated diseases, highlighting Johnson & Johnson's commitment to innovation in Immunodermatology and the development of novel treatment options for immune-mediated conditions.