- Phase 3 ICONIC ADVANCE 1 & 2 and ICONIC‑LEAD reported 52‑week data for icotrokinra (ICOTYDE), a targeted oral peptide that blocks the IL‑23 receptor.
- PASI100 rose from 41%→49% (ADVANCE 1) and 33%→48% (ADVANCE 2) between Week 24 and Week 52, with placebo switchers achieving ~50% and 43% by Week 52.
- Adolescents in ICONIC‑LEAD showed 57% PASI100 and 61% IGA 0 at Week 52, and 86% reached PASI90 with 92% maintaining PASI90 from Week 24–52.
- No new safety signals through Week 52; overall adverse event and infection rates were lower than deucravacitinib through Week 24, and ICOTYDE is approved in the U.S. for patients ≥12 years and ≥40 kg at 200 mg once daily on an empty stomach.
ICONIC Phase 3 program and mechanism
Phase 3 ICONIC‑ADVANCE 1 & 2 and ICONIC‑LEAD evaluated icotrokinra (ICOTYDE), an oral peptide that blocks the IL‑23 receptor with single‑digit picomolar affinity (clinical significance unknown).
Efficacy at Week 52
In ICOTYDE arms PASI100 increased from 41% to 49% (ADVANCE‑1) and 33% to 48% (ADVANCE‑2) between Week 24 and Week 52; patients switching from placebo at Week 16 reached similar PASI100 by Week 52 (~50% and 43%).
Adolescent outcomes
ICONIC‑LEAD (n=684; ICOTYDE=456, placebo=228) enrolled 66 adolescents: 57% achieved PASI100 and 61% IGA 0 at Week 52; 86% reached PASI90 at one year and 92% maintained PASI90 from Week 24–52.
Safety, approval and dosing
No new safety signals were identified through Week 52; overall adverse event and infection rates were lower than deucravacitinib through Week 24; ICOTYDE is approved in the U.S. for patients ≥12 years and ≥40 kg at 200 mg once daily taken on an empty stomach 30 minutes before eating.
