J&J(US:JNJ) Prnewswire·2025-10-27 11:30Core Insights - Icotrokinra, a first-in-class targeted oral peptide developed by Johnson & Johnson, has shown promising results in the Phase 2b ANTHEM-UC study for treating moderately to severely active ulcerative colitis, with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement at Week 28 compared to placebo [1][2][3] Clinical Results - At Week 28, all doses of icotrokinra (100 mg, 200 mg, and 400 mg) demonstrated higher rates of clinical response, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI) compared to placebo [1][2] - The clinical response rates for the 400 mg dose were 66.7% at Week 28, up from 63.5% at Week 12, while clinical remission improved from 30.2% to 31.7% [2] - Endoscopic improvement increased from 36.5% at Week 12 to 38.1% at Week 28, with HEMI rates rising from 28.6% to 33.1% [2] Safety Profile - Similar proportions of participants reported adverse events and serious adverse events across all icotrokinra dose groups and the placebo group, indicating a favorable safety profile [2][3] Future Development - Johnson & Johnson has initiated Phase 3 clinical development for icotrokinra in both adults and adolescents with moderately to severely active ulcerative colitis and Crohn's disease [3] - The company is also studying icotrokinra in pivotal Phase 3 programs for moderate-to-severe plaque psoriasis and active psoriatic arthritis [3][9] Mechanism of Action - Icotrokinra is designed to precisely block the IL-23 receptor, which plays a critical role in the inflammatory response associated with ulcerative colitis and other IL-23-mediated diseases [8][9] Regulatory Status - A New Drug Application (NDA) for icotrokinra was submitted to the U.S. Food and Drug Administration (FDA) in July 2025, seeking approval for treating adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis [3]