Icotrokinra Shows Promise in Ulcerative Colitis
Johnson & Johnson announced positive topline results from ANTHEM-UC, a Phase IIb study of icotrokinra (JNJ 2113 / JNJ 77242113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC)
The study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at Week 12.
In the ANTHEM-UC study (n=252), three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27% for placebo (p<0.001). Further, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo (p<0.001). Remission and response rates continued to improve through Week 28. Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.
“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, 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 being prepared for presentation at upcoming medical congresses.
About ANTHEM-UC: ANTHEM-UC (NCT06049017) is a Phase IIb multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally.
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