Clinical TrialJun 21, 2026, 05:00 PM
MoonLake SLK Phase 3 VELA HS Trial Shows Strong Wk 52 Results; BLA Sep 2026
AI Summary
MoonLake Immunotherapeutics announced positive Week 52 results from its Phase 3 VELA clinical trials for sonelokimab (SLK) in moderate-to-severe hidradenitis suppurativa (HS), demonstrating consistent and superior efficacy compared to competing agents, alongside a consistent safety profile. The company also reported strong interim Week 24 data from the VELA-TEEN trial in adolescent HS patients. A Biologics License Application (BLA) for SLK in HS, including adolescent data, is expected to be submitted by the end of September 2026, with a request for Priority Review. An Investor Day webcast is scheduled for June 22, 2026, to discuss these data and upcoming events.
Key Highlights
- ~67% of adult HS patients achieved HiSCR75 at Week 52 in VELA trials.
- ~33% of adult HS patients achieved HiSCR100 at Week 52.
- ~26% of adult HS patients achieved inflammatory remission (IHS4-100) at Week 52.
- Mean HiSQOL improved by -15.0 points at Week 52, indicating severe to mild impairment.
- ~46.5% of adult HS patients experienced marked pain reduction (≥3-point NRS).
- ~68% of adolescent HS patients achieved HiSCR75 at Week 24 in VELA-TEEN trial.
- Biologics License Application (BLA) for SLK in HS expected end of September 2026.
- Investor Day webcast scheduled for June 22, 2026.
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