NEWARK, CALIFORNIA — October 7, 2025 — Leads & Copy — Protagonist Therapeutics, Inc. has announced positive Week 12 results from its Phase 2b ANTHEM-UC study of icotrokinra, an oral peptide that blocks the IL-23 receptor, in adults with ulcerative colitis (UC). The study met its primary endpoint, with all dose groups showing clinical response and improvements versus placebo.
The 400 mg icotrokinra group achieved a 63.5% clinical response rate versus 27% for placebo (p<0.001). Significant improvements in clinical remission, symptomatic remission, and endoscopic improvement were also observed in the 400 mg group compared to placebo. All icotrokinra doses demonstrated higher rates of symptomatic remission compared to placebo as early as Week 4. Similar proportions of participants reported adverse events across all groups.
Based on the Phase 2b results, a Phase 3 trial in ulcerative colitis will be initiated. Icotrokinra is also being studied in plaque psoriasis and psoriatic arthritis. A New Drug Application (NDA) was submitted to the FDA in July 2025 for the treatment of adults and pediatric patients with moderate to severe plaque psoriasis.
“The data supports the thesis of IL-23R targeted oral peptide icotrokinra as a potential treatment option in a range of inflammatory and immunological diseases,” said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist.
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Source: Protagonist Therapeutics, Inc.
