MoonLake Immunotherapeutics AG (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, announced that it is proceeding with a global Phase 2 clinical study to evaluate sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (“HS”).
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Subsequent to the completion of a global Phase 2b clinical study in moderate-to-severe psoriasis (NCT03384745), the new protocol for HS was filed as part of MoonLake‘s Investigational New Drug (“IND”) with the U.S. Food and Drug Administration. The review process was inclusive of a Type C meeting, as well as the statutory 30-day review period during which no additional comments were received. Approval for the protocol was obtained from the central Institutional Review Board.
The global, randomized, double-blind, placebo-controlled study (M1095-HS-201, “MIRA”) is designed 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. This study represents a landmark in HS clinical development, as it will be 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.
The study 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 pain and quality of life assessments. Patient enrollment is expected to start imminently in 2022, with the first sites being initiated in the United States.
Sonelokimab (M1095) is an investigational Nanobody® designed to treat inflammatory disease by inhibiting 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.
Kristian Reich, Founder and Chief Scientific Officer at MoonLake, commented: “We believe this is a landmark moment for patients with such a devastating disease as HS. Using an at least 75% improvement of HiSCR as the primary endpoint reflects our goal to reach for a greater reduction in disease markers than is typically tested in clinical trials. By binding to IL-17A and IL-17F, sonelokimab inhibits the naturally occurring IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation in HS. Furthermore, the Nanobody® characteristics of sonelokimab should improve its tissue penetration, helping the molecule to target difficult-to-reach inflammatory lesions such as deep abscesses and tunnels, which are hallmarks of HS. We are excited to continue development of the first IL-17A- and IL-17F-targeting Nanobody® as a potential novel treatment for chronic inflammatory conditions such as HS, with the aim of elevating outcomes for patients.”