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MoonLake Immunotherapeutics has launched the Phase 3 VELA program, testing the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). The program aims to enroll 800 patients and is expected to report its topline primary endpoint at week 16 by mid-2025. Sonelokimab targets inflammation by inhibiting IL-17A/A, IL-17A/F, and IL-17F/F dimers. The Phase 3 program, following the successful Phase 2 MIRA trial, will use HiSCR75 as its primary endpoint. The trial will last 52 weeks, with an open-label extension up to two years.
MoonLake Immunotherapeutics reported positive feedback on the regulatory path for the Phase 3 program of Nanobody® sonelokimab, significant improvements in ARGO Phase 2 trial, and plans to commence four additional clinical trials across dermatology and rheumatology. The company ended Q1 2024 with $547.1 million in cash and expects a cash runway to the end of 2026.