MoonLake announces feedback from FDA, EMA on path for sonelokimab program

MoonLake Immunotherapeutics announced the outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration, as well as positive feedback from its interactions with the E.U. European Medicines Agency, with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody sonelokimab in hidradenitis suppurativa. The Phase 3 program, named VELA, is expected to enroll 800 patients and in combination with the data from Phase 2 MIRA trial will support both a Biologics License Application and E.U. Marketing Authorization Application. The Phase 3 trial design will compare a single SLK dose to placebo over a 16-week period, with the placebo group subsequently transitioning to SLK 120mg. The primary endpoint and key secondary endpoints read out at week 16. The VELA trial program is designed to run for 52 weeks followed by an open-label extension The number of patients, the straightforward trial design, the similarity of protocol to the Phase 2 trial, and the identification of the HS dose, collectively, enhance the clarity of SLK’s clinical development and displays promise for the HS franchise. The readout of the primary endpoint is anticipated in mid-2025. Additionally, MoonLake plans to have an end-of-Phase 2 meeting with the FDA regarding its psoriatic arthritis (PsA) program in Q2 2024 and begin the Phase 3 program in Q4 2024.