MoonLake provides update following positive feedback from U.S. FDA for SLK

MoonLake Immunotherapeutics (MLTX) provided an update following the positive feedback received from the U.S. Food and Drug Administration, FDA, regarding the clinical evidence strategy for Sonelokimab, SLK, in HS, based on the Type B meeting requested by MoonLake. SLK was associated with significant improvements across different key outcomes in over 1,000 patients with HS enrolled in the MIRA, VELA-1 and VELA-2 trials. MIRA was the first placebo-controlled randomized clinical trial in HS using HiSCR75 as the primary endpoint and demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies. In VELA-2, using the pre-specified treatment policy strategy, SLK achieved statistical significance. A higher-than-expected placebo response precluded this study from achieving statistical significance using the primary composite analysis method. All trials consistently suggested a favorable safety profile of SLK in HS patients.