Key Takeaways:
MoonLake Immunotherapeutics on Sunday reported Week 52 data from its Phase 3 VELA program showing 67.2% of patients with moderate-to-severe hidradenitis suppurativa treated with sonelokimab achieved HiSCR75, a measure of at least 75% reduction in abscess and inflammatory nodule count.
"The final Week 52 data from the VELA program confirm the strength of SLK across most, if not all, metrics that matter in HS," Jorge Santos da Silva, founder and chief executive officer of MoonLake, said in a statement. "Together with the alignment we have reached with the FDA on our HS label strategy, these data support the potential for a highly differentiated label profile."
Across both VELA-1 and VELA-2 trials, 33.1% of patients achieved HiSCR100, meaning complete clearance of abscesses and inflammatory nodules, and 26.0% reached IHS4-100, defined as inflammatory remission with 100% reduction in abscesses, nodules and draining tunnels. The results were consistent across the two studies, with VELA-1 showing 68.3% HiSCR75 and VELA-2 showing 66.0% HiSCR75. Relative to a competing IL-17A and IL-17F inhibitor monoclonal antibody, sonelokimab showed approximately 10 percentage points more responding patients across HiSCR75, HiSCR100 and IHS4-100, according to the company.
Patients treated with sonelokimab reported a mean improvement of 15.0 points on the Hidradenitis Suppurativa Quality of Life score, shifting from "severe" to "mild" impairment on average. Clinically meaningful improvement on the broader Dermatology Life Quality Index was seen in 75.0% of VELA-1 patients and 69.4% of VELA-2 patients. Nearly half of patients — 46.5% — experienced at least a three-point reduction in worst skin pain on the Numerical Rating Scale. No new safety signals were detected through Week 52, and approximately 90% of patients rolled over into the two-year open-label extension, validating the tolerability of the 120-milligram once-every-four-weeks dosing regimen.
Interim Week 24 data from the VELA-TEEN trial in adolescent patients aged 12 to 17 showed approximately 68% achieved HiSCR75, 86% achieved HiSCR50 and 45% achieved HiSCR100, with no new safety signals. The response rates in adolescents exceeded those seen in the adult program at comparable time points, suggesting earlier intervention may slow disease progression to irreversible tissue damage.
MoonLake plans to submit a Biologics License Application to the Food and Drug Administration at the end of September 2026, with clarity on the Prescription Drug User Fee Act date expected by the end of November 2026. The company will request Priority Review based on sonelokimab's profile and the adolescent data. If granted, Priority Review could reduce time to market by approximately one quarter; without it, MoonLake expects a third or fourth quarter 2027 launch.
The data position sonelokimab as a potential best-in-class therapy in a hidradenitis suppurativa market projected to reach $15 billion by 2035, according to the company. MoonLake shares have gained 45.75% year to date, giving the company a market capitalization of $1.41 billion. Investors will watch the company's Investor Day webcast on June 22 for further guidance on commercialization plans and upcoming milestones, including the mid-2026 readout of the Phase 3 IZAR-1 trial in psoriatic arthritis.
This article is for informational purposes only and does not constitute investment advice.
