MoonLake Immunotherapeutics (NASDAQ:MLTX) stock is trading higher on Monday after the company reported encouraging 52-week results from its Phase 3 VELA-1 and VELA-2 studies evaluating sonelokimab (SLK) for moderate-to-severe hidradenitis suppurativa (HS).
The data released on Sunday showed sustained improvements in disease control, quality of life, and pain reduction.
The clinical-stage biotech also said it remains on track to submit a Biologics License Application (BLA) for SLK to the FDA by the end of September 2026.
In March, MoonLake announced that 62% of patients treated with sonelokimab achieved a HiSCR75 response by Week 40, setting a new standard for long-term lesion control in HS.
Strong One-Year Efficacy Across MoonLake Phase 3 Program
Pooled data from both Phase 3 studies showed that 67.2% of patients receiving SLK achieved HiSCR75 at Week 52, while 33.1% reached HiSCR100. Results were broadly consistent across both VELA trials.
Additionally, 26% of treated patients achieved an IHS4-100 response, indicating complete resolution of inflammatory lesions, including abscesses, nodules, and draining tunnels.
MoonLake said the long-term outcomes compared favorably with previously reported Phase 3 studies involving competing HS therapies, noting that SLK generated higher response rates across several efficacy measures.
Quality Of Life And Pain Scores Continue To Improve
The company said clinical improvements translated into meaningful patient benefits.
Patients treated with SLK recorded substantial gains in HS-specific quality-of-life measures, with average HiSQOL score improvements of 15.3 points in VELA-1 and 14.8 points in VELA-2.
Broader dermatology quality-of-life assessments also improved, with 75% of patients in VELA-1 and 69.4% in VELA-2 achieving clinically meaningful responses.
Nearly half of eligible patients experienced significant reductions in skin pain, defined as at least a three-point improvement from baseline.
Placebo Crossover And Teen Data Support Broader Potential
Patients who switched from placebo to SLK after Week 16 experienced rapid improvements, with HiSCR75 response rates increasing by roughly 20 percentage points within four weeks.
After 36 weeks of treatment, crossover patients posted response rates comparable to those who received continuous SLK therapy.
MoonLake also released interim Week 24 data from the Phase 3 VELA-TEEN study.
Approximately 68% of adolescent patients achieved HiSCR75, while 45% achieved HiSCR100. The company said no new safety concerns emerged in the adolescent population.
The safety profile across the VELA program remained consistent, with no new safety signals identified.
MoonLake expects the FDA to determine whether to grant Priority Review when it accepts the BLA, with a potential commercial launch anticipated in the second half of 2027.
MLTX Stock Price Activity: MoonLake shares were up 20.15% at $23.08 during premarket trading on Monday, according to Benzinga Pro data.
Image via Shutterstock
Recent Comments