MoonLake Immunotherapeutics Receives Unanimous Support for Phase 3 Trial of Sonelokimab in Hidradenitis Suppurativa from FDA and EMA

MoonLake Immunotherapeutics Receives Unanimous Support for Phase 3 Trial of Sonelokimab in Hidradenitis Suppurativa from FDA and EMA

Company: MoonLake Immunotherapeutics Indication: Hidradenitis Suppurativa (HS) Drug: Sonelokimab (SLK) Trial Phase: Phase 3 NCT ID: NCT05322473

Overview

MoonLake Immunotherapeutics, a clinically-focused biopharmaceutical company, has announced a significant milestone with unanimous support from the U.S. FDA and the European EMA for the Phase 3 trial of their drug candidate, sonelokimab, for the treatment of Hidradenitis Suppurativa.

VELA Phase 3 Program

  • Participants: 800 individuals with HS
  • Design: Randomized, double-blind, placebo-controlled study
  • Dosage: 120mg dose of SLK vs placebo
  • Duration: 16-weeks with a primary endpoint, followed by 52-week continuation and open-label extension
  • Primary Outcome Measure: HiSCR75
  • Review of Outcomes: Expected by mid-2025
  • Start of Trial: Q2 2024

Company Commitments

  • MoonLake aims for a rapid start to the Phase 3 program for HS
  • Preparation for end-of-Phase 2 discussions for ongoing psoriatic arthritis trials, with Phase 3 anticipated in late 2024

Sonelokimab (SLK)

SLK is an investigational Nanobody® that selectively inhibits IL-17A and IL-17F, which are key players in inflammation. This therapeutic candidate has demonstrated favorable outcomes in earlier trials, including the ARGO trial in Psoriatic Arthritis (PsA) and the MIRA trial in HS.

Additional Information

MoonLake will provide detailed insights into HS and PsA programs in the upcoming R&D Day event. For more information on the MIRA trial or other company announcements, stakeholders are encouraged to visit MoonLake's official website or the clinical trials registry.