MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

Core Insights - MoonLake Immunotherapeutics has initiated the Phase 3 VELA program for sonelokimab, targeting moderate-to-severe hidradenitis suppurativa (HS) with a primary endpoint of HiSCR75 [1][3][4] - The program aims to enroll 800 patients across two identical trials, VELA-1 and VELA-2, with topline results expected by mid-2025 [3][5][6] - Sonelokimab is designed to inhibit IL-17A and IL-17F, addressing a significant unmet need in HS treatment [2][18] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on developing sonelokimab, a novel investigational Nanobody® for inflammatory diseases [18] - The company was founded in 2021 and is headquartered in Zug, Switzerland [18] Product Details - Sonelokimab is a ~40 kDa humanized Nanobody® that selectively binds to IL-17A and IL-17F, facilitating targeted treatment of inflammation [7][18] - The drug is currently being evaluated for HS and psoriatic arthritis (PsA), with plans for additional indications in dermatology and rheumatology [8][10] Clinical Trial Information - The Phase 3 VELA program will assess the efficacy and safety of sonelokimab over 52 weeks, with a focus on achieving a ≥75% reduction in total abscess and inflammatory nodule count [3][6] - The trials will also evaluate secondary endpoints, including HiSCR50 and changes in quality of life metrics [6] Market Context - HS affects up to 4.1% of the global population, with significant morbidity and a market opportunity exceeding $10 billion by 2035 [2][17] - There is a critical need for new treatment options, as only two biologics are currently FDA approved for HS [4][17]