MoonLake completes patient enrollment in Phase 2 trial of Nanobody sonelokimab

MoonLake Immunotherapeutics announced that it has completed enrollment of the target 210 patients randomized ahead of schedule in its global Phase 2 clinical trial evaluating sonelokimab in moderate-to-severe hidradenitis suppurativa, HS. The MIRA trial is the first global, randomized, double-blind, placebo-controlled trial using Hidradenitis Suppurativa Clinical Response, HiSCR, 75, a higher measure of clinical response, as its primary endpoint. It is evaluating different doses of sonelokimab, compared with placebo, with adalimumab as an active control reference arm, in patients with HS, a severely debilitating chronic skin condition, that results in irreversible tissue destruction. Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: "The rapid completion of enrollment and randomization for our Phase 2 trial reflects the need for new treatment options and the clinical interest in evaluating the Nanobody(R) sonelokimab in hidradenitis suppurativa. In our view, and based on competitive data, sonelokimab’s ability to efficiently inhibit IL-17F in addition to IL-17A could represent a major improvement in treating inflammation for this devastating disease. Sonelokimab’s smaller size versus traditional antibodies and albumin-binding domain provide an opportunity for further efficacy. We thank patients and investigators for their participation in this important trial, and remain on schedule to announce top line results on the primary endpoint by mid-2023."