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Protagonist Announces New Icotrokinra Data in Ulcerative Colitis and Plaque Psoriasis Presented at Two Recent Medical Conferences

  • Protagonist Therapeutics announced new clinical data for icotrokinra, a first-in-class oral peptide blocking the IL-23 receptor, presented at recent medical conferences on October 27, 2025.
  • Week 28 results from the Phase 2b ANTHEM-UC study showed 31.7% of patients achieved clinical remission & 38.1% showed endoscopic improvement versus placebo for ulcerative colitis.
  • All tested doses (100 mg, 200 mg, 400 mg) of icotrokinra demonstrated higher rates of clinical response, remission, endoscopic improvement, & histologic-endoscopic mucosal improvement (HEMI) compared to placebo at Week 28.
  • Johnson & Johnson initiated the Phase 3 ICONIC-UC protocol for ulcerative colitis & the Phase 2b/3 ICONIC-CD protocol for Crohn's disease based on the ANTHEM-UC results.
  • Phase 3 ICONIC-TOTAL study data at Week 52 showed 72% of patients with scalp psoriasis & 85% with genital psoriasis achieved site-specific clear or almost clear skin.
  • In the ICONIC-TOTAL study, 67% of patients achieved overall clear or almost clear skin by Week 24, a rate maintained through Week 52, with 44% achieving completely clear skin.
  • Patients with hand/foot psoriasis showed increased clearance rates from 42% at Week 16 to 62% at Week 52.
  • Safety data through Week 52 revealed no new adverse events, with adverse event & serious adverse event rates remaining similar to Week 16 levels.
  • The company noted comparable overall response rates between patients treated with icotrokinra for 52 weeks & those who transitioned from placebo to icotrokinra at Week 16.