MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab

Core Insights - MoonLake Immunotherapeutics announced week 16 results from Phase 3 VELA-1 and VELA-2 trials for sonelokimab in treating moderate-to-severe hidradenitis suppurativa (HS) [1][4][29] - The trials demonstrated statistically significant improvements in primary and key secondary endpoints, indicating the efficacy of sonelokimab [4][6][7] - The company plans to discuss these results with regulatory authorities to confirm the path to registration for HS [14][32] Group 1: Trial Design and Results - The VELA program utilized HiSCR 75 as the primary endpoint, requiring a 75% reduction in abscess and inflammatory nodule count [2][29] - A total of 838 patients were enrolled in the trials, which compared a single 120mg dose of sonelokimab to placebo [2][4] - In VELA-1, sonelokimab achieved a HiSCR75 response rate of 34.8% compared to 17.5% for placebo, while VELA-2 showed 35.9% versus 25.6% [6][8] Group 2: Efficacy and Safety - Sonelokimab demonstrated statistically significant improvements across all primary and key secondary endpoints with p-values below 0.001 [4][7] - The treatment policy strategy indicated a clinically meaningful benefit, with nearly 60% of patients achieving a DLQI improvement of at least 4 points [7][8] - The safety profile of sonelokimab remained favorable, with no new safety signals detected [10][12] Group 3: Future Developments - The company is advancing other clinical studies for sonelokimab, including trials for adolescent HS and psoriatic arthritis [4][14][21] - The VELA program is expected to progress to a week 52 readout, with further data anticipated to support regulatory submissions [4][14] - MoonLake aims to address the significant unmet need for effective treatments in HS, a condition affecting approximately 2% of the population [32][33]