FDA and EMA back MoonLake's Phase 3 program for sonelokimab in psoriatic arthritis

MoonLake Immunotherapeutics

FDA and EMA unanimously supported MoonLake's proposed Phase 3 IZAR program for sonelokimab in PsA.
Phase 3 design: ~1,500 patients across two trials (IZAR-1 bio-naïve, IZAR-2 TNF-IR with risankizumab reference).
Doses 60mg and 120mg; primary endpoint ACR50 at week 16; first patient Q4 2024, topline readout end-2026.
Follows positive FDA/EMA feedback for HS Phase 3 VELA program; Phase 3 HS recruitment already started.
Phase 2 ARGO data plus IZAR intended to support BLA and EU MAA for sonelokimab in PsA.

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