MoonLake Immunotherapeutics Receives Endorsement from FDA and EMA for Phase 3 Program of Sonelokimab in Treating Hidradenitis Suppurativa
MoonLake Immunotherapeutics, an innovative biopharmaceutical company, has received the green light from key health authorities—the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)—for the advancement of their Phase 3 clinical trial of Sonelokimab (SLK) for the treatment of Hidradenitis Suppurativa (HS).
Company: MoonLake Immunotherapeutics Indication: Hidradenitis Suppurativa Drug: Sonelokimab (SLK) Phase: Phase 3 Clinical Trial Registration: NCT05322473
Trial Design
The Phase 3 trial, dubbed 'VELA', is poised to build upon the data from Phase 2 'MIRA' studies. It intends to include approximately 800 participants in its efforts to support regulatory submissions for a Biologics License Application in the US, and a Marketing Authorization Application in the EU.
The 'VELA' trial will employ a 16-week head-to-head test comparing a single dose of SLK (120mg) to a placebo, followed by a transition stage allowing the placebo group to receive SLK. The outcome measure of HiSCR75, along with important secondary outcomes, will be evaluated at the end of 16 weeks, with the study continuing for a total of 52 weeks, succeeded by an open-label extension phase.
Clinical and Regulatory Milestones
- First patient enrolment is expected to begin in Q2 2024.
- Primary endpoint results are anticipated by mid-2025.
- An end-of-Phase 2 meeting is planned for MoonLake's Psoriatic Arthritis program, with Phase 3 set to start by Q4 2024.
MoonLake's approach entails leveraging the proven effectiveness from previous Phase 2 results, establishing a larger patient pool, and identifying a potent HS dose that bears the promise of shaping the future of HS treatment. An R&D Day event is in the works to shed more light on the development of both the HS and Psoriatic Arthritis programs.
Founded in 2021 and headquartered in Zug, Switzerland, MoonLake Immunotherapeutics is focused on the development of Sonelokimab and its potential to revolutionize the management of inflammatory diseases.