Core Viewpoint - MoonLake Immunotherapeutics' stock price plummeted over 90% following the release of disappointing week-16 results from its Phase 3 VELA-1 and VELA-2 trials for sonelokimab, despite achieving statistical significance in primary and secondary endpoints [1][8]. Group 1: Trial Design and Results - A total of 838 patients were enrolled in the VELA trials, which compared a single 120mg dose of sonelokimab to placebo, with primary endpoint HiSCR75 assessed at week 16 [2]. - Both VELA-1 and VELA-2 trials achieved statistical significance for all key endpoints, including lesion counts and patient-reported outcomes, with p-values below 0.001 [3]. - Sonelokimab showed a statistically significant HiSCR75 response as early as week 4 in both studies [3]. Group 2: Efficacy and Patient Outcomes - At week 16, 34.8% of patients in VELA-1 and 35.9% in VELA-2 achieved HiSCR75, while placebo response rates were 17.5% and 25.6%, respectively [5]. - Approximately 30% of patients reported a significant reduction in pain, with at least a 3-point improvement in the worst pain NRS in both trials [6]. - Nearly 60% of patients experienced a meaningful improvement of 4 points or more in the Dermatology Quality of Life Index (DLQI), representing a 20 percentage-point benefit over baseline [7]. Group 3: Safety and Future Outlook - The safety profile of sonelokimab remained favorable, consistent with previous studies, and no new safety signals were reported [7]. - Preliminary analyses indicate that responses may continue to improve beyond week 16, with placebo patients achieving similar responses to those initially randomized to sonelokimab by week 20 [4].