Press release
MoonLake Immunotherapeutics starts Phase 2 trial of the Nanobody® Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa
MoonLake Immunotherapeutics starts Phase 2 trial of the Nanobody® Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa First Phase 2 trial
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"MoonLake Immunotherapeutics starts Phase 2 trial of the Nanobody® Sonelokimab in patients with moderate-to-severe hidradenitis suppurativa First Phase 2 trial in hidradenitis suppurativa using the higher clinical response level of HiSCR75 as the primary endpointTrial evaluates sonelokimab, an investigational Nanobody® with an innovative mode of action designed to treat and elevate patient outcomes for inflammatory disease ZUG, Switzerland, May 12, 2022 – MoonLake Immunotherapeutics AG (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that the first patient has been randomized and dosed, in a U.S. site, in its global Phase 2 clinical trial evaluating sonelokimab, an investigational Nanobody® designed to treat inflammatory disease, in patients with moderate-to-severe hidradenitis suppurativa (HS). HS is a severely debilitating chronic skin condition, with a prevalence of approximately 1% globally, that results in irreversible tissue destruction. Sonelokimab (M1095) inhibits the naturally occurring IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. In addition, sonelokimab is designed to directly target sites of inflammation and penetrate difficult-to-reach inflamed tissues. The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of different doses of sonelokimab, compared with placebo, with adalimumab as an active control reference arm, in over 200 patients with HS. This trial represents a landmark milestone in HS clinical development as it is the first to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint. 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. Using an at least 75% improvement of HiSCR as the primary endpoint reflects MoonLake’s goal to revolutionize patient outcomes by seeking a greater reduction in disease markers than is typically tested in clinical trials. The trial will also include a range of secondary endpoints reflecting the heterogeneous clinical phenotypes of the disease, including inflammatory lesions and tunnels, as well as a number of patient-reported outcome measures such as p...