MoonLake gets FDA & EMA support for Phase 3 sonelokimab in hidradenitis suppurativa

MoonLake Immunotherapeutics

FDA and EMA both support Phase 3 design for sonelokimab (SLK) in HS; trial named VELA.
Phase 3 will enroll 800 patients; single 120mg dose vs placebo over 16 weeks; primary endpoint HiSCR75.
First patient randomization expected Q2 2024; primary endpoint readout mid-2025.
Combined Phase 2 and Phase 3 data to support BLA and EU marketing application.
End-of-Phase 2 meeting for PsA with FDA expected Q2 2024; Phase 3 start Q4 2024.

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