MoonLake Immunotherapeutics AG announced that 12-week Phase 2 MIRA trial data for the Nanobody®? sonelokimab in hidradenitis suppurativa will be presented at the European Academy of Dermatology and Venereology Congress taking place from October 11-14 in Berlin, Germany. In June 2023, MoonLake announced positive topline 12-week Phase 2 MIra trial results, achieving a landmark milestone as the first placebo-controlled randomized trial in HS to report positive top-line results using HiSCR75 as the primary endpoint.

Professor Brian Kirby MD, FRCPI, Charles Department of Dermatology, St. Vincent's University Hospital and Charles Institute of Dermatology, University College Dublin, Dublin, Ireland will be presenting the results in a late-breaking news presentation, details of which are included below. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab is currently being assessed in two ongoing trials, the Phase 2 MIRA trial in HS and the Phase 2 ARGO trial in PsA. The MIRA trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75 which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials. A significantly greater proportion of patients treated with both sonelokimab 120mg and 240mg achieved HiSCR75 compared to those on placebo at week 12.

The positive results suggest that, as early as week 12, sonelokimab, relative to placebo, reaches the highest clinical activity among all other therapies tested in similarly stringent pivotal-like trials.