SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) announced promising topline data from its Phase 2b ANTHEM-UC clinical trial evaluating icotrokinra (JNJ-2113) as a treatment for moderately to severely active ulcerative colitis (UC). The investigational targeted oral peptide, designed to selectively block the IL-23 receptor, achieved its primary endpoint of clinical response across all dose groups tested and demonstrated significant improvements over placebo in key secondary metrics such as clinical remission, symptomatic remission, and endoscopic improvement.
The study involved 252 participants and tested three once-daily doses of icotrokinra. At Week 12, the highest dose group achieved a clinical response rate of 63.5%, compared to 27% in the placebo group (p<0.001). Clinical remission was seen in 30.2% of patients treated with the highest dose, compared to 11.1% on placebo (p<0.01). These positive results improved further through Week 28, aligning with recent encouraging data from the Phase 3 plaque psoriasis program.
Icotrokinra was well-tolerated, with adverse event rates comparable between treatment and placebo groups.
“These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment,” said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology at Johnson & Johnson. “With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.”
Comprehensive results from the ANTHEM-UC study are expected to be shared at upcoming medical conferences. The findings underscore the potential of icotrokinra as a safe and effective, patient-friendly treatment option for ulcerative colitis.
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