MoonLake Immunotherapeutics said week 52 data from its phase 3 VELA program showed 67.2% of patients treated with sonelokimab achieved HiSCR75 at one year, while 33.1% reached HiSCR100 and 26.0% achieved IHS4-100, a measure of inflammatory remission.
The company said the results were broadly similar across the two trials: in VELA-1, 68.3% hit HiSCR75 and 31.2% hit HiSCR100; in VELA-2, 66.0% reached HiSCR75 and 35.1% reached HiSCR100. Week 52 remission rates were 24.4% in VELA-1 and 27.7% in VELA-2.
Patient-reported outcomes also improved over the year. The mean change in HiSQOL from baseline was -15.3 points in VELA-1 and -14.8 points in VELA-2, while the combined program showed a -15.0-point difference versus baseline. On the broader DLQI measure, 75.0% of VELA-1 patients and 69.4% of VELA-2 patients had at least a 4-point improvement.
Pain scores improved as well: 46.5% of patients had at least a 3-point reduction in worst skin pain, including 48.4% in VELA-1 and 44.3% in VELA-2.
MoonLake said the week 52 results were stronger than those seen in competing phase 3 hidradenitis suppurativa programs, and said responses were more than 10 percentage points higher on HiSCR75, HiSCR100 or IHS4-100 versus a comparator IL-17A/F antibody.
In the crossover group, patients who switched from placebo to sonelokimab at week 16 saw HiSCR75 rates rise by about 20 percentage points after four weeks of treatment, and by the end of the VELA program their HiSCR75 response was about 60%, similar to the 36-week response in the continuous-treatment group.
The company also reported that about 90% of patients rolled over into the two-year open-label extension, supporting the once-every-four-weeks dosing schedule.
In the adolescent VELA-Teen trial, about 68% of patients achieved HiSCR75 at week 24, about 86% reached HiSCR50, and about 45% achieved HiSCR100. MoonLake said the adolescent response rates were higher than those seen in the adult program at comparable time points.
MoonLake plans to submit its biologics license application for hidradenitis suppurativa at the end of September 2026. It expects clarity on the PDUFA date by the end of November 2026. If priority review is not granted, the company expects a launch in the third or fourth quarter of 2027; if it is granted, the time to market could be shortened by about one quarter. As a result of these announcements, the company's shares have moved 14.91% on the market, and are now trading at a price of $22.075. Check out the company's full 8-K submission here.
