MoonLake Immunotherapeutics Receives Regulatory Green Light for Phase 3 Program

By Tamara Parker • Monday, February 26 16:30 • Permanent Link

Moonlake Immunotherapeutics (NASDAQ:MLTX) has received positive feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on its regulatory path for the phase 3 program of the nanobody® Sonelokimab (SLK) in Hidradenitis Suppurativa (HS). The phase 3 program, named Vela, is expected to enroll 800 patients and will support both a Biologics License Application (BLA) and EU Marketing Authorization Application.

Moonlake Immunotherapeutics plans to begin the phase 3 program in the second quarter of 2024, with the first patient expected to be randomized in that period. The primary endpoint readout is anticipated in mid-2025. Additionally, the company announced that it will have an end-of-phase 2 meeting with the FDA regarding its Psoriatic Arthritis (PSA) program in the second quarter of 2024 and begin the phase 3 program in the fourth quarter of 2024.

The phase 3 trial design will compare a single SLK dose (120mg) to placebo over a 16-week period, with the placebo group subsequently transitioning to SLK 120mg. The primary endpoint (Hidradenitis Suppurativa Clinical Response 75 * HISCR75) and key secondary endpoints will read out at week 16. The Vela trial program is designed to run for 52 weeks followed by an open-label extension (OLE).

The company's CEO, Dr. Jorge Santos da Silva, expressed appreciation for the support from both regulatory agencies and highlighted the clear regulatory path for Sonelokimab in Hidradenitis Suppurativa. He emphasized the potential innovative treatment option that this represents for patients and their physicians, addressing a condition that significantly impacts patients' lives.

Moonlake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on creating next-level therapies for inflammatory diseases. Sonelokimab, the company's investigational nanobody®, inhibits IL-17A and IL-17F by targeting the dimers that drive inflammation. It is being assessed in trials for both Hidradenitis Suppurativa and Psoriatic Arthritis. Following these announcements, the company's shares moved 0.1%, and are now trading at a price of $52.12. Check out the company's full 8-K submission here.

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