Switzerland - MoonLake Immunotherapeutics ( MoonLake ; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, announced that positive 12-week results from its global Phase 2 MIRA trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa ( HS ) were presented today during a late-breaking session at the European Academy of Dermatology and Venereology Congress ( EADV ) held in Berlin, Germany.

The EADV presentation follows the announcement, in June 2023, of the positive topline 12-week results from the trial in 234 patients, which marked a landmark milestone as the first placebo-controlled randomized trial in HS to report results using HiSCR75 as the primary endpoint. The primary analysis was based on the most stringent type of analysis for such trials, intent-to-treat non-responder imputation ( ITT-NRI ).

The MIRA trial met its primary endpoint with a significantly higher proportion of patients treated with both sonelokimab 120mg (43.3%) and 240mg (34.8%) achieving HiSCR75 compared to those on placebo (14.7%) at week 12. Sonelokimab also met the key secondary endpoint with a significantly higher proportion of patients treated with both sonelokimab 120mg (65.7%) and 240mg (53.0%) achieving HiSCR50 compared to those on placebo (27.9%) at week 12. Both doses performed similarly, with the 120mg dose providing the highest delta on HiSCR75 and HiSCR50. The 120mg dose achieved a 29 percentage points (ppt) delta to placebo on HiSCR75 (p

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