MoonLake’s Sonelokimab Shows Promise in Adolescent HS Despite Adult Trial Setback

MoonLake Therapeutics’ sonelokimab has demonstrated potential in treating hidradenitis suppurativa (HS) among adolescents, following positive results from the Phase III VELA-TEEN trial. The study showed that 46% of participants achieved a Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at 16 weeks, marking a 75% reduction in inflammatory lesions. While the drug failed to outperform UCB’s Bimzelx in adult HS trials (VELA-1 and VELA-2), MoonLake plans to pursue a biologics licence application, with a Type B FDA meeting scheduled for December 2025.

Despite an 88% stock plunge after the adult trial results, MoonLake’s shares are gradually recovering. The company also reported success in the Phase II LEDA trial for palmoplantar pustulosis (PPP), showing a 64% drop in severity scores. A Phase III PPP study is expected in 2026. Although Bimzelx dominates the adult HS market, sonelokimab could secure a niche as the first therapy targeting adolescent HS patients.

11-11-2025