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Protagonist Announces Presentation of One-Year Phase 3 Data for ICOTYDE(TM) in Moderate-to-Severe Plaque Psoriasis at the 2026 American Academy of Dermatology (AAD) Annual Meeting

PTGX
  • Protagonist Therapeutics presented one-year Phase 3 data for ICOTYDE at the 2026 AAD Annual Meeting, demonstrating lasting skin clearance & a favorable safety profile.
  • ICOTYDE is the first & only targeted oral peptide designed to block the IL-23 receptor for moderate-to-severe plaque psoriasis.
  • Phase 3 ICONIC-ADVANCE 1 & 2 studies showed durable complete skin clearance through Week 52 with no new safety signals.
  • Patients switching from placebo to ICOTYDE at Week 16 achieved similar complete skin clearance rates by Week 52 as those on continuous treatment.
  • ICOTYDE adverse event & infection rates were lower than deucravacitinib through Week 24.
  • The ICONIC-LEAD study showed nearly 60% of adolescents achieved completely clear skin at one year, with 86% achieving PASI 90 & 92% maintaining that response from Week 24 to Week 52.
  • Johnson & Johnson holds commercial responsibility for ICOTYDE under a 2017 collaboration agreement, with Protagonist eligible for tiered royalties & milestone payments.
  • ICOTYDE is currently approved in the U.S. for adults & pediatric patients 12 years & older weighing at least 40 kg.
  • Patients take one ICOTYDE pill once daily upon waking on an empty stomach, waiting 30 minutes before eating.
  • The drug is also in Phase 3 studies for psoriatic arthritis, ulcerative colitis, & Crohn's disease.
  • Major safety warnings include increased infection risk, requiring screening for tuberculosis before treatment initiation.
  • Common side effects include headache, nausea, cough, fungal infection, & tiredness.