MoonLake announces positive 24-week Phase 2 MIRA results; 57% HiSCR75, 120mg dose confirmed for Phase 3

MoonLake Immunotherapeutics

57% of patients on sonelokimab 120mg achieved HiSCR75 at week 24 (+10 ppt from week 12); 38% achieved HiSCR90 (+14 ppt).
Complete inflammatory remission (IHS4-100) in 24% of patients; 31% AN 100 and 49% DT 100 at week 24 with 120mg.
120mg Q4W maintenance dose confirmed as optimal based on efficacy, safety, and pharmacokinetics; safety consistent with IL-17 class.
Adalimumab non-responders switching to sonelokimab at week 12 achieved HiSCR75 rates similar to patients randomized to sonelokimab at baseline.
Company on track to discuss Phase 3 development plans with FDA by end of 2023.

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