MoonLake’s Sonelokimab Achieves 67% HiSCR75, 33% HiSCR100 at Week 52
MLTX•MoonLake’s Phase 3 VELA trial at Week 52 showed 67.2% achieved HiSCR75, 33.1% HiSCR100 and 26% IHS4-100 with a 15-point HiSQOL gain and no new safety signals. VELO-TEEN Week 24 data in adolescents reported 68% HiSCR75 and 45% HiSCR100, and BLA submission is planned for September 2026.
1. VELA Phase 3 Week 52 Efficacy
In the combined VELA-1 and VELA-2 trials (n=396), 67.2% of patients treated with sonelokimab achieved HiSCR75 and 33.1% reached HiSCR100 at Week 52. Additionally, 26.0% achieved complete inflammatory remission (IHS4-100) and the mean HiSQOL score improved by 15 points from baseline.
2. VELA-TEEN Adolescent Outcomes
Interim Week 24 data in adolescent patients (n=22) showed rapid responses with 68% achieving HiSCR75, 86% HiSCR50 and 45% HiSCR100. Sonelokimab was well tolerated and demonstrated higher response rates than the adult cohort at comparable timepoints.
3. Safety and Tolerability
No new safety signals emerged through Week 52 across adult and adolescent programs, supporting a consistent tolerability profile. Approximately 90% of patients rolled over into the two-year open-label extension on the 120 mg once-every-four-weeks dosing regimen.
4. Regulatory Pathway and Investor Day
MoonLake plans to submit a Biologics License Application for sonelokimab in hidradenitis suppurativa by end of September 2026. An Investor Day webcast is scheduled for June 22, 2026, to discuss data and upcoming milestones.
