MoonLake reported positive 52-week Phase 3 VELA results for sonelokimab in hidradenitis suppurativa, with 67.2% of patients achieving HiSCR75 and a planned FDA BLA submission in September 2026.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
MoonLake Immunotherapeutics has reported final 52-week results from its Phase 3 VELA-1 (NCT06411899) and VELA-2 trials (NCT06411379) evaluating sonelokimab in adults with moderate-to-severe hidradenitis suppurativa (HS), demonstrating sustained efficacy, meaningful quality-of-life improvements, and a consistent safety profile. The company plans to submit a Biologics License Application (BLA) to the U.S. FDA by the end of September 2026.
Across the pooled Phase 3 program, 67.2% of patients treated with sonelokimab achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 52, while 33.1% achieved HiSCR100. Inflammatory remission, measured by IHS4-100, was observed in 26.0% of patients. No new safety signals were identified during one year of treatment.
Durable Responses in Phase 3 VELA Program
The global VELA program enrolled 838 adults with active moderate-to-severe HS across two randomized, placebo-controlled Phase 3 studies. Sonelokimab met the primary endpoint in the pooled program at Week 16 and continued to improve clinical outcomes through one year.
In addition to strong lesion clearance, patients reported meaningful improvements in quality of life and symptom burden. HiSQOL scores improved by approximately 15 points from baseline, while nearly half of treated patients achieved at least a three-point reduction in worst skin pain scores.
Although cross-trial comparisons should be interpreted cautiously, the Week 52 efficacy outcomes appear numerically higher than long-term responses reported in pivotal studies of approved HS biologics, including adalimumab and secukinumab. MoonLake noted that sonelokimab showed more than a 10-percentage-point advantage across several key efficacy measures compared with previously reported data from competing IL-17 inhibitors.
Sonelokimab is a Nanobody® that target both IL-17A and IL-17F, cytokines known to drive inflammation in HS. The therapy is administered as a 120 mg maintenance dose once every four weeks, a schedule that may reduce treatment burden and support long-term adherence.
Positive Results Extend to Adolescents
MoonLake also reported interim Week 24 results from the Phase 3 VELA-TEEN study (NCT06768671), the first dedicated Phase 3 trial evaluating sonelokimab in adolescents with HS.
Approximately 68% of patients achieved HiSCR75, 86% achieved HiSCR50, and nearly 45% achieved HiSCR100. No new safety signals were observed, supporting the therapy’s safety profile across both adult and adolescent populations.
FDA Filing Planned for September 2026
Chief Executive Officer Jorge Santos da Silva said the Week 52 findings reinforce sonelokimab’s potential to deliver durable disease control, meaningful patient benefit, and convenient monthly dosing.
MoonLake has completed pre-BLA interactions with the FDA and plans to submit a BLA under Section 351 of the Public Health Service Act by late September 2026. The company intends to request Priority Review based on the therapy’s clinical profile and supportive adolescent data.
FDA acceptance of the application and assignment of a Prescription Drug User Fee Act (PDUFA) date are expected by the end of November 2026. If Priority Review is granted, regulatory action could occur in 2027. If approved, sonelokimab could become the first Nanobody® therapy available for hidradenitis suppurativa.
What the Results Could Mean for Patients
For people living with hidradenitis suppurativa, the benefits of sonelokimab may extend beyond clearing skin lesions. After one year of treatment, many patients reported less pain, better quality of life, and improved control of their disease, helping them manage symptoms that can affect daily activities, work, sleep, and emotional well-being. With a once-every-four-week maintenance dosing schedule, sonelokimab may also offer a more convenient treatment option that could make long-term therapy easier for patients to maintain.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.