MoonLake Receives FDA and EMA Approval for Sonelokimab Phase 3 Program in HS

MoonLake Immunotherapeutics has received favorable responses from both the U.S. FDA and the EMA regarding their pathway for Phase 3 trials of sonelokimab (SLK) for hidradenitis suppurativa (HS). This positive feedback validates MoonLake's Phase 3 program design, which includes a study population of 800 patients supplemented by Phase 2 trial participants.

The Phase 3 trial will assess the efficacy of a single 120mg dose of SLK over a 16-week period, after which the placebo group will transition to SLK 120mg. The principal outcome measure (HiSCR75) and major secondary endpoints will be examined at 16 weeks. The entire trial is structured to span 52 weeks with an open-label extension. This cohesive structure, combined with the alignment to the Phase 2 methodology, facilitates clearer clinical development strategies and augurs well for the HS treatment franchise. The primary endpoint results are anticipated by the middle of 2025.

MoonLake’s CEO, Dr. Jorge Santos da Silva, appreciates the regulatory bodies' alignment with the company's clinical objectives, emphasizing the importance of these developments in offering a potential new treatment for HS, a condition with significant unmet treatment needs.

In addition to HS, MoonLake plans to convene a meeting with the FDA for its psoriatic arthritis (PsA) program in the second quarter of 2024 and aims to start the Phase 3 PsA trial by the fourth quarter of the same year.

MoonLake remains focused on its innovative treatments for inflammatory diseases, driven by the benefits of sonelokimab. This investigational therapy has shown promising results in trials, targeting IL-17A and IL-17F to curb inflammation.

Sonelokimab is currently being evaluated in both HS and PsA. The Phase 2 MIRA trial for HS demonstrated positive results, meeting its primary endpoint with significant improvements in clinical response markers. Similarly, the Phase 2 ARGO trial for PsA also showed that sonelokimab achieved its primary endpoint, with patients on both tested dosages demonstrating superior outcomes compared to the placebo group.

Sonelokimab has also undergone a Phase 2b trial for plaque-type psoriasis, which also yielded promising results. Positive outcomes were observed, including high clinical response thresholds and a safety profile comparable to existing therapies.

The Phase 3 MIRA trial for HS enrolled 234 participants and aims to validate the efficacy of two dosages of sonelokimab against both placebo and adalimumab, a known active control. The trial’s primary goal is to determine the percentage of participants achieving a significant reduction in symptoms, such as abscesses and inflammatory nodules.

MoonLake is committed to advancing its clinical programs, aiming to revolutionize treatments for inflammatory diseases and improve patient outcomes with novel therapeutic solutions.