ACCESS Newswire·Oct 7, 2025, 8:10 AM ET

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 in the Phase 2b ANTHEM-UC study for ulcerative colitis at Week 12.
At the highest 400 mg dose, 36.5% of patients achieved endoscopic improvement & 30.2% achieved clinical remission.
Clinical response rates at Week 12 were 63.5% for the 400 mg group, 58.1% for the 200 mg group, & 54.7% for the 100 mg group versus 27% for placebo.
Patients across all icotrokinra dose groups demonstrated significantly greater proportions of clinical remission, symptomatic remission, & endoscopic improvement compared to placebo.
Higher rates of symptomatic remission were observed in all icotrokinra groups compared to placebo as early as Week 4.
The safety profile of icotrokinra showed similar proportions of adverse events & serious adverse events across all dose groups & the placebo group through Week 12.
A registrational Phase 3 study in ulcerative colitis & a Phase 2b/3 study in Crohn's disease are anticipated to begin patient enrollment in Q4 2025.
Icotrokinra is also being studied in Phase 3 trials for plaque psoriasis & psoriatic arthritis, with a New Drug Application (NDA) for psoriasis submitted to the FDA in July 2025.
Protagonist Therapeutics announced the initiation of a Phase 1 study for its oral IL-17 targeted peptide PN-881.
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor & was discovered by Protagonist & Johnson & Johnson.