MoonLake: Positive Feedback from FDA. EMA on Phase 3 Program in Hidradenitis Suppurativa

 

• Clarified path for HS Phase 3 program with study design, patient population and endpoints agreed
• One dose of SLK (120mg) to be tested with a similar protocol as in Phase 2
• Total Phase 3 population of 800 patients to be complemented by Phase 2 population for registration
• Phase 3 trial has similar design to validated Phase 2 trial and in line with the Company’s communications and expectations
• First patient expected to be randomized in Q2 2024, primary endpoint readout expected mid-2025
• Further details to be provided in upcoming R&D Day

https://www.globenewswire.com/news-release/2024/02/26/2835058/0/en/MoonLake-Immunotherapeutics-Announces-Positive-Feedback-from-both-FDA-and-EMA-on-Regulatory-Path-for-the-Phase-3-Program-of-the-Nanobody-sonelokimab-SLK-in-Hidradenitis-Suppurativa.html