Andrzej Rostek
MoonLake Immunotherapeutics (NASDAQ:MLTX) said it has received feedback from the FDA and European Medicines Agency on its proposed Phase 3 study for its drug sonelokimab in the treatment of hidradenitis suppurativa, or HS.
The biotech company said it received guidance on the Phase 3 study’s design, patient population and endpoints, with both the FDA and EMA supporting its proposed approach. The study’s design is similar to its Phase 2 clinical trial.
MoonLake said it expects to have a primary endpoint readout for the Phase 3 study in mid-2025.
The company also plans to meet with regulators in Q2 to discuss the pathway for sonelokimab in the treatment of psoriatic arthritis. MoonLake intends to begin Phase 3 testing for the condition in Q4 2024.