US traded shares of Swiss biotech MoonLake Immunotherapeutics (Nasdaq: MLTX) leapt almost 79% to $46.58 this morning, after the inflammatory diseases specialist announced positive top-line results from its global Phase II MIRA trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS).
MoonLake was established in May 2021, at which time it in-licensed the tri-specific Nanobody sonelokimab (M1095/ALX 0761) from Germany’s Merck KGaA (MRK: DE).
The MIRA trial (M1095-HS-201), which recruited 234 patients, is the first randomized, double-blind, placebo-controlled trial to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint, a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, therefore representing a landmark milestone in HS clinical development.
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