ZUG, Switzerland, June 21, 2026
MoonLake Immunotherapeutics has announced compelling Week 52 results from its Phase 3 VELA clinical program, reinforcing the potential of sonelokimab (SLK) as a leading treatment for patients suffering from moderate-to-severe hidradenitis suppurativa (HS), a chronic and debilitating inflammatory skin disease. The latest findings demonstrated sustained efficacy, significant improvements in quality of life, meaningful reductions in pain, and a favorable safety profile after one year of treatment. The company also revealed promising interim data from its Phase 3 VELA-TEEN trial in adolescent patients and confirmed plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration by the end of September 2026. The results strengthen MoonLake’s position in the rapidly growing inflammatory disease market and support expectations that sonelokimab could become a best-in-class therapy for HS.
Phase 3 VELA Program Demonstrates Durable Clinical Benefits
The final one-year analysis from the VELA-1 and VELA-2 studies showed that approximately 67% of patients achieved HiSCR75, a stringent measure indicating a 75% reduction in abscesses and inflammatory nodules, while 33% achieved complete HiSCR100 response, demonstrating complete resolution of inflammatory lesions. Additionally, 26% of treated patients reached inflammatory remission (IHS4-100), highlighting sonelokimab’s ability to deliver deep and sustained disease control. Patient-reported outcomes also remained highly encouraging. Participants experienced significant improvements in HS-specific quality of life (HiSQOL) scores, moving on average from severe impairment to mild disease impact. Nearly half of all treated patients reported substantial reductions in skin pain, a critical outcome for individuals living with HS.
Importantly, no new safety concerns emerged during the 52-week treatment period, further validating the long-term tolerability of the therapy. These results compare favorably with outcomes reported in previous clinical trials of competing biologic therapies and underscore the differentiated profile of MoonLake’s investigational Nanobody® candidate.
Adolescent Trial Data Expand Future Treatment Opportunities
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MoonLake also disclosed interim findings from its VELA-TEEN Phase 3 trial, the first dedicated study evaluating sonelokimab in adolescents with moderate-to-severe HS. Results showed that nearly 68% of adolescent patients achieved HiSCR75, while approximately 45% achieved HiSCR100, indicating exceptionally strong therapeutic activity in younger patients. The response rates observed in adolescents exceeded those seen in adult studies at similar time points, suggesting that earlier intervention may provide enhanced clinical benefits and potentially slow disease progression before irreversible tissue damage occurs.
Safety findings remained consistent with previous studies, with no new adverse signals reported. The adolescent data are expected to be included in MoonLake’s upcoming regulatory submission, potentially supporting a broader label and expanding access to treatment for a younger patient population with significant unmet medical needs.
Regulatory Milestones and Commercial Outlook Strengthen Growth Strategy
Following successful completion of the pre-BLA process, MoonLake plans to submit its BLA for sonelokimab in hidradenitis suppurativa by the end of September 2026. The company intends to seek Priority Review designation based on the therapy’s robust efficacy profile and positive adolescent data package. If granted, Priority Review could accelerate regulatory timelines and potentially bring the therapy to market sooner than expected. Beyond HS, MoonLake continues to advance a broad inflammatory disease pipeline, including Phase 3 programs in psoriatic arthritis (PsA) and additional studies in axial spondyloarthritis and palmoplantar pustulosis.
Company executives believe the combined efficacy, safety, dosing convenience, and quality-of-life improvements demonstrated by sonelokimab position the therapy as a transformative treatment candidate capable of redefining long-term outcomes for patients with chronic inflammatory diseases worldwide. The Week 52 VELA results represent a major milestone in MoonLake’s clinical development strategy and reinforce confidence in the commercial potential of its innovative Nanobody® platform.
Source: MoonLake Immunotherapeutics press release
