• Results from the Phase 3 VELA clinical trials at Week 52 in adults with moderate-to-severe hidradenitis suppurativa (HS) demonstrate sonelokimab’s (SLK) potential best-in-class and best-in-disease profile, with consistent responses that are higher than those observed in trials of competing agents at the end of their respective parental trials
  • Namely, ~67% of patients treated with SLK achieved HiSCR75 at the one-year mark, with more than one quarter of patients achieving inflammatory remission (IHS4-100), and around one third reaching HiSCR100
  • Patients treated with SLK likewise showed substantial improvement in HiSQOL at Week 52, with a mean score difference between end of trial and baseline of -15.0 points, indicating an average change from "severe" to "mild" impairment of the HS-related quality of life
  • Almost half of the patients experienced a marked reduction in pain (at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale (NRS))
  • No new safety signals were detected in the VELA trials to date, supporting a consistent safety profile through Week 52
  • Data from the VELA-TEEN trial in adolescent HS patients show strong therapeutic response and no new safety signals in adolescent patients, with nearly 70% of patients achieving HiSCR75 at Week 24 and almost half of patients reaching HiSCR100
  • Submission of the Biologics License Application (BLA) for SLK in HS, including data from adolescent patients, is expected at the end of September 2026, and will follow previous agency guidance on the label strategy
  • An Investor Day webcast will be held on June 22, 2026, 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), to discuss these data and provide guidance on upcoming events