MoonLake Gets Support From FDA, EMA For Nanobody Sonelokimab Phase 3 Program

(RTTNews) - Biotechnology company, MoonLake Immunotherapeutics (MLTX), Monday announced positive outcomes from its interactions with the U.S. Food and Drug Administration or FDA, and the E.U. European Medicines Agency or EMA about the Phase 3 program, named VELA, of Nanobody sonelokimab in hidradenitis suppurativa or HS.

Hidradenitis suppurativa is a chronic, inflammatory skin disease, where lumps develop in areas such as armpits, groin, and buttocks due to rubbing of skin.

VELA is expected to start in the second quarter of 2024 with 800 patients, where a single SLK dose of 120 mg will be compared to a placebo over 16 weeks. The primary endpoint will be read out by mid-2025.

Further, the company stated that the end-of-Phase 2 meeting with the FDA regarding the psoriatic arthritis program will be held in the second quarter of 2024, followed by the Phase 3 program in the fourth quarter of the same year.

In the pre-market activity, MoonLake's stock is trading at $52.99, up 1.81 percent on the Nasdaq.