Protagonist Announces New Icotrokinra Data in Ulcerative Colitis Showing Potential for a Standout Combination of Therapeutic Benefit and a Favorable Safety Profile in Once-daily Pill

Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated achieving endoscopic improvement and 30.2% achieving clinical remission at the highest dose at Week 12 in the Phase 2b ANTHEM-UC study

These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis

Registrational Phase 3 study in ulcerative colitis and Phase 2b/3 study in Crohn’s disease anticipated to begin patient enrollment in Q4 2025

Excerpt from the Press Release:

NEWARK, CALIFORNIA / ACCESS Newswire / October 7, 2025 / Protagonist Therapeutics, Inc. (“Protagonist” or the “Company”) today announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class 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, with all once-daily icotrokinra dose groups achieving clinical response^a at Week 12 and showing clinically meaningful improvements versus placebo across key secondary endpoints.¹ These results underscore the potential of icotrokinra to deliver a valuable combination of significant therapeutic benefit and a favorable safety profile with once-daily oral dosing and are featured at United European Gastroenterology (UEG) Week 2025.

At Week 12, patients treated with 400 mg of icotrokinra once daily achieved a clinical response rate of 63.5% versus 27% for placebo (p<0.001), while patients treated with 200 mg and 100 mg of icotrokinra once daily achieved 58.1% and 54.7% response rates, respectively.¹

Across multiple secondary endpoints, in the 400 mg icotrokinra group, significantly greater proportions of patients achieved clinical remission, symptomatic remission, and endoscopic improvement at Week 12 compared to placebo. Both the 200 mg and 100 mg once-daily dosing groups also showed meaningful improvements in these secondary endpoints relative to placebo.

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