Clinical TrialJun 22, 2026, 07:07 AM
MoonLake SLK Phase 3 VELA Week 52 Results Positive; BLA Q3 2026
AI Summary
MoonLake Immunotherapeutics announced positive Week 52 results from its Phase 3 VELA clinical trials for sonelokimab (SLK) in adult patients with moderate-to-severe hidradenitis suppurativa (HS), showing consistent and improved efficacy compared to competitors. Additionally, interim Week 24 data from the Phase 3 VELA-TEEN trial in adolescent HS patients demonstrated rapid onset and high response rates with no new safety signals. The company plans to submit the Biologics License Application (BLA) for SLK in HS by the end of September 2026, with PDUFA date clarity expected by late November 2026.
Key Highlights
- Sonelokimab achieved 67.2% HiSCR75 and 33.1% HiSCR100 in adult HS at Week 52.
- 26.0% of adult HS patients achieved IHS4-100 inflammatory remission at Week 52.
- SLK demonstrated ~10% higher response rates than competitors for key endpoints.
- Interim VELA-TEEN data showed ~68% HiSCR75 in adolescent HS patients at Week 24.
- No new safety signals were observed across all VELA clinical programs.
- BLA submission for sonelokimab in HS is expected by the end of September 2026.
- PDUFA date clarity for the HS BLA is anticipated by the end of November 2026.
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