MoonLake's Sonelokimab Achieves Outstanding Week 52 Phase 3 VELA Results in Hidradenitis Suppurativa, De-risking September BLA Filing
On June 21, 2026, MoonLake Immunotherapeutics announced highly positive final Week 52 (one-year) results from its global registrational Phase 3 program (comprising the VELA-1 and VELA-2 clinical trials) evaluating sonelokimab (SLK), an investigational anti-IL-17A and IL-17F Nanobody®, in adults with moderate-to-severe hidradenitis suppurativa (HS).
The data demonstrate sonelokimab’s potential best-in-class and best-in-disease profile, showing durable clinical responses and substantial quality-of-life improvements that outperform competing therapies. The company also reported strong interim Week 24 results from its Phase 3 VELA-TEEN trial in adolescents.
With the pre-BLA process concluded, MoonLake plans to submit its Biologics License Application (BLA) to the FDA at the end of September 2026.
Key Week 52 Clinical Efficacy Results
The final one-year data showed consistent and further improvements in clinical scores compared to Week 16:
- HiSCR75: 67.2% of patients treated with SLK achieved a 75% reduction in total abscess and inflammatory nodule count (HiSCR75) at Week 52 (n=396). Results were highly consistent across both trials (VELA-1: 68.3%, VELA-2: 66.0%).
- HiSCR100: 33.1% of patients achieved a complete 100% resolution of lesions (HiSCR100) at Week 52 (VELA-1: 31.2%, VELA-2: 35.1%).
- IHS4-100 (Inflammatory Remission): 26.0% of patients achieved complete inflammatory remission, defined as a 100% reduction in abscesses, nodules, and draining tunnels (VELA-1: 24.4%, VELA-2: 27.7%).
MoonLake highlighted that these long-term results are superior to prior Phase 3 HS programs with competing agents, including a competitor IL-17A & F monoclonal antibody, where sonelokimab showed over a ~10% higher responder rate across HiSCR75, HiSCR100, and IHS4-100 metrics:
"Across both VELA-1 and VELA-2, 67.2% of patients treated with SLK achieved HiSCR75 and 33.1% of patients achieved HiSCR100 at Week 52 (n=396)... Relative to the competitor IL-17-A & F inhibitor monoclonal antibody, the SLK Nanobody®, for example, showed responses with over ~10% more responding patients for HiSCR75, HiSCR100 or IHS4-100."
Substantial Quality-of-Life and Pain Improvements
Sustained clinical efficacy was accompanied by dramatic improvements in patient-reported outcomes:
- Quality of Life (HiSQOL): Patients showed a mean score difference of -15.0 points between end of trial and baseline, indicating an average change from "severe" to "mild" impairment of HS-related quality of life.
- Skin Dermatology Life Quality Index (DLQI): Clinically meaningful response (≥4-point improvement) was achieved by 75.0% (VELA-1) and 69.4% (VELA-2) of patients.
- Skin Pain Reduction: 46.5% of patients experienced a marked reduction in pain (at least a 3-point improvement in the worst skin pain Numerical Rating Scale).
VELA-TEEN Adolescent Data
Interim Week 24 results from the Phase 3 VELA-TEEN trial in adolescent patients with moderate-to-severe HS showed rapid onset and highly pronounced clinical response:
- 68% of adolescent patients achieved HiSCR75 at Week 24.
- 86% achieved HiSCR50 and 45% achieved HiSCR100 (n=22).
- The safety profile in adolescents was consistent with adults, with no new safety signals detected:
"HiSCR75 rates in VELA‑TEEN were higher than those observed in the adult VELA program at comparable timepoints, indicating a pronounced clinical response in adolescent patients with earlier stage disease. SLK was generally well tolerated in this vulnerable patient population, and no new safety signals were observed."
Next Steps and BLA Timeline
MoonLake has concluded all pre-BLA regulatory meetings with the FDA and is preparing for a formal submission:
- Late September 2026: Planned BLA submission to the FDA, which will include the adolescent VELA-TEEN data.
- Late November 2026: Expected FDA BLA acceptance and PDUFA target action date allocation.
- Dosing Convenience: The high tolerability of SLK was validated by a ~90% rollover rate into the two-year Open-Label Extension (VELA-OLE) study, supporting the convenience of the 120mg Q4W (once every four weeks) dosing regimen.
MoonLake intends to request a Priority Review for the BLA. If granted, the time-to-market could be reduced by approximately one quarter, enabling an earlier launch in 2027. If Priority Review is not granted, MoonLake expects a launch in the third or fourth quarter of 2027.
"MoonLake plans to submit the BLA for HS to the FDA at the end of September 2026. The pre-BLA process is concluded and no more regulatory meetings with the FDA will take place. Clarity on the Prescription Drug User Fee Act (PDUFA) date is currently expected by the end of November 2026, concurrent with the FDA’s acceptance of the BLA."