Protagonist Therapeutics announced positive topline results from the Phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113) in adults with moderately to severely active ulcerative colitis (UC). The study, conducted by collaboration partner Johnson & Johnson, met its primary endpoint of clinical response across all icotrokinra dose groups evaluated.
The highest dose achieved a clinical response rate of 63.5% and a clinical remission rate of 30.2% at Week 12, with these rates continuing to improve through Week 28. The study also demonstrated clinically meaningful differences versus placebo in key secondary endpoints, including clinical remission, symptomatic remission, and endoscopic improvement at Week 12.
Icotrokinra was well tolerated, with similar proportions of participants reporting adverse events between the icotrokinra dose groups and the placebo group. These promising results highlight icotrokinra's potential to offer a transformative oral treatment option for patients with ulcerative colitis.
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