Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 20 hours ago
- 1 min read
21/06/2026
MoonLake Immunotherapeutics announced Phase 3 results for sonelokimab in Hidradenitis Suppurativa (Ref)
MoonLake Immunotherapeutics announced the week 52 results from its Phase 3, VELA-1 and VELA-2 trials of sonelokimab (SLK; IL-17 A/F inhibitor) for the treatment of patients with moderate-to-severe Hidradenitis Suppurativa (HS).
At week 52, sonelokimab showed consistent and further improvement in all clinical scores compared to week 16 data.
Across both VELA-1 and VELA-2 trials (Pooled as observed), 67.2% of patients achieved HiSCR75 and 33.1% achieved HiSCR100 and 26.0% reaching IHS4-100 inflammatory remission.
Patient-reported outcomes improved, with a HiSQOL mean change from baseline of −15.3 (VELA-1) and −14.8 (VELA-2) and a ≥3-point reduction in worst skin pain NRS in 46.5% of patients.
No new safety signals were detected in the VELA trials to date, supporting a consistent safety profile through Week 52.
Interim Week 24 data from the adolescent VELA-TEEN trial showed ~68% HiSCR75, ~86% HiSCR50 and ~45% HiSCR100, with no new safety signals.
The company expected to submit the BLA for HS, including data from adolescent patients, is expected at the end of September 2026, with PDUFA date clarity anticipated by end of November 2026.
The company plans to request Priority Review.
