J&J(US:JNJ) Prnewswireยท2025-10-07 12:05Core 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]