Press release
MoonLake Immunotherapeutics completes patient enrollment and randomization ahead of schedule in a Phase 2 trial of the Nanobody® sonelokimab in moderate-to-severe hidradenitis suppurativa
MoonLake Immunotherapeutics completes patient enrollment and randomization ahead of schedule in a Phase 2 trial of the Nanobody® sonelokimab in
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[{"type":"text","content":"MoonLake Immunotherapeutics completes patient enrollment and randomization ahead of schedule in a Phase 2 trial of the Nanobody® sonelokimab in moderate-to-severe hidradenitis suppurativa Enrollment target of 210 patients randomized completed ahead of scheduleTop line results on the primary endpoint, for the novel IL-17A and IL-17F inhibitor Nanobody® sonelokimab, expected mid-2023First registered randomized trial in HS to use HiSCR75 as the primary endpoint; trial also includes adalimumab as an active reference armThe trial will proceed to its 24-week completion, including placebo patients re-randomized to sonelokimab and adalimumab patients switched to sonelokimab, with final read out expected, as planned, by Q4 2023 ZUG, Switzerland, February 2, 2023 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today 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 (M1095-HS-201) 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. Sonelokimab (M1095) is a Nanobody® designed to directly target sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers and to penetrate difficult-to-reach inflamed tissues. HiSCR75 is defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The use of HiSCR75 as a primary endpoint in an HS clinical trial is a reflection of MoonLake’s confidence in sonelokimab and the Company’s ambition to revolutionize patient outcomes by seeking a greater reduction in disease markers than is typically tested in clinical trials. The trial also includes a range of secondary endpoints reflecting the heterogeneous clinical phenotypes of the ...