ZUG, Switzerland - MoonLake Immunotherapeutics, a clinical-stage biopharmaceutical company, has received unanimous support from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its Phase 3 program of the investigational Nanobody® sonelokimab (SLK) for treating hidradenitis suppurativa (HS), a chronic inflammatory skin condition.
The Phase 3 trial, named VELA, is set to begin in the second quarter of 2024 with an expected primary endpoint readout by mid-2025.
The VELA trial will enroll 800 patients and, along with data from the Phase 2 MIRA trial, will support regulatory submissions for a Biologics License Application in the U.S. and a Marketing Authorization Application in the E.U.
The trial will compare a single dose of SLK (120mg) to a placebo over a 16-week period, with the placebo group transitioning to SLK after this period. The primary endpoint, HiSCR75, measures a significant clinical response in HS symptoms, with results anticipated at week 16. The trial is designed to last 52 weeks, followed by an open-label extension.
Dr. Jorge Santos da Silva, CEO of MoonLake Immunotherapeutics, expressed gratitude for the regulatory agencies' support and emphasized the importance of this development for HS patients and healthcare providers.
In addition to the HS program, MoonLake is planning an end-of-Phase 2 meeting with the FDA regarding its psoriatic arthritis program in the second quarter of 2024, with the Phase 3 program expected to commence in the fourth quarter of the same year. Further details on both the HS and PsA programs will be provided during an upcoming R&D Day.
MoonLake Immunotherapeutics specializes in developing novel therapies for inflammatory diseases by leveraging the potential of sonelokimab, a Nanobody® that inhibits inflammatory mediators IL-17A and IL-17F. The company was founded in 2021 and is based in Zug, Switzerland.
This article is based on a press release statement from MoonLake Immunotherapeutics.
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