Core 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]

Core Insights - Icotrokinra, a first-in-class targeted oral peptide, has shown promising results in treating moderately to severely active ulcerative colitis, achieving a clinical response rate of 36.5% at the highest dose in the Phase 2b ANTHEM-UC study [1][2] - The study met its primary endpoint, demonstrating significant improvements across key secondary endpoints compared to placebo, indicating the potential of icotrokinra as a new treatment option [1][2] - Johnson & Johnson has initiated further clinical trials, including the ICONIC-UC Phase 3 protocol for ulcerative colitis and additional studies for Crohn's disease and psoriasis [3][4] Study Results - At Week 12, the clinical response rates for icotrokinra were 63.5% for the 400 mg dose, 58.1% for the 200 mg dose, and 54.7% for the 100 mg dose, compared to 27% for placebo [2] - Significant improvements in clinical remission, symptomatic remission, and endoscopic improvement were observed in the 400 mg group compared to placebo, with p-values indicating statistical significance [2] - All icotrokinra doses showed higher rates of symptomatic remission as early as Week 4 compared to placebo [2] Future Developments - Johnson & Johnson is advancing icotrokinra into Phase 3 trials for ulcerative colitis and Crohn's disease, reflecting the company's commitment to addressing inflammatory bowel diseases [3][4] - A New Drug Application (NDA) for icotrokinra has been submitted to the FDA for the treatment of moderate to severe plaque psoriasis, indicating the drug's potential across multiple indications [3][9] Background Information - Ulcerative colitis is a chronic inflammatory condition of the colon, characterized by symptoms such as abdominal pain, diarrhea, and rectal bleeding, which can significantly impact patients' quality of life [8] - Icotrokinra selectively blocks the IL-23 receptor, which is involved in the inflammatory response associated with ulcerative colitis and other related diseases [9]