As reported on Healio, new phase 3 data suggest that sonelokimab may offer durable disease control for patients with moderate to severe hidradenitis suppurativa (HS), with more than two-thirds of treated adults achieving a substantial clinical response after one year of therapy. Interim findings from an adolescent study also indicate strong efficacy and a favorable safety profile in younger patients.
Long-Term Adult Data Highlight Durable Disease Control
MoonLake Immunotherapeutics reported topline results from its phase 3 VELA-1 and VELA-2 trials, which evaluated sonelokimab in 838 adults with moderate to severe HS. The investigational therapy is a humanized nanobody designed to inhibit the inflammatory cytokines IL-17A and IL-17F while using an albumin-binding component intended to enhance tissue penetration.
Participants were randomized to receive sonelokimab 120 mg subcutaneously every four weeks following an induction regimen or placebo. Individuals initially assigned to placebo crossed over to active treatment after 16 weeks.
At week 52, the primary endpoint of Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)—defined as at least a 75% reduction in abscesses and inflammatory nodules—was achieved by 68.3% of patients in VELA-1 and 66.0% in VELA-2. These findings represent an improvement over previously reported interim results and demonstrate sustained efficacy over one year.
According to Alexa B. Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, long-term outcomes are particularly important in HS because of the disease’s chronic and recurring nature. She noted that approximately two out of every three treated patients reached the demanding HiSCR75 benchmark after one year.
Meaningful Rates of Complete Disease Clearance
Beyond the primary endpoint, investigators reported notable rates of complete lesion clearance. More than one-third of participants achieved HiSCR100, which reflects complete resolution of abscesses and inflammatory nodules without worsening draining tunnels.
Rates of HiSCR100 were 31.2% in VELA-1 and 35.1% in VELA-2, indicating consistent results across both studies.
Researchers also observed substantial reductions in overall disease burden using the International Hidradenitis Suppurativa Severity Score System (IHS4). Approximately one-quarter of treated participants reached IHS4-100, indicating complete elimination of active lesions and draining tunnels.
Patients who transitioned from placebo to sonelokimab at week 16 experienced rapid improvement, with HiSCR75 response rates increasing by roughly 20 percentage points within four weeks of starting active treatment. By the conclusion of the trials, their outcomes were comparable to those of patients who received sonelokimab from the outset.
Improvements Extend to Quality of Life
The clinical gains were accompanied by meaningful patient-reported benefits.
Across both studies, participants experienced an average 15.3-point improvement from baseline on the HS-specific Quality of Life Score by week 52. Additionally, about three-quarters of patients in VELA-1 and nearly 70% in VELA-2 achieved at least a four-point improvement on the Dermatology Life Quality Index (DLQI), a commonly used measure of skin disease impact on daily living.
These findings suggest that reductions in inflammatory lesions translated into tangible improvements in physical comfort, emotional well-being, and everyday functioning.
Adolescent Study Produces Promising Early Findings
MoonLake also released interim data from VELA-TEEN, an open-label phase 3 study evaluating sonelokimab in adolescents aged 12 to 17 years with moderate to severe HS.
The analysis included 22 participants who received 120 mg of sonelokimab every two weeks through week 6, followed by maintenance dosing every four weeks beginning at week 8.
By week 24:
- 68% achieved HiSCR75
- 86% achieved HiSCR50
- 45% achieved HiSCR100
Notably, HiSCR75 response rates in the adolescent cohort appeared higher than those observed in adults at similar time points in the VELA program.
The treatment was reported to be well tolerated, with no new safety concerns identified during the study period.
Kimball described the findings as encouraging, particularly given the limited treatment data available for adolescents with HS. Although the study remains small, she noted that the early results may help inform future management strategies for younger patients.
Regulatory Milestones Ahead
Based on the positive phase 3 program results, MoonLake plans to submit a Biologics License Application (BLA) for sonelokimab, accompanied by a request for priority review. The company anticipates receiving feedback from the U.S. Food and Drug Administration regarding both the review designation and a Prescription Drug User Fee Act (PDUFA) timeline later this year.
If approved, sonelokimab could become a new treatment option for patients with moderate to severe hidradenitis suppurativa, offering the potential for sustained disease control, substantial lesion clearance, and improved quality of life.
