MoonLake sonelokimab Phase 3 VELA Week 52 hidradenitis suppurativa 67 percent HiSCR75 33 percent HiSCR100
For the roughly 1 in 100 people living with hidradenitis suppurativa, a painful chronic skin disease with few good options, MoonLake $MLTX reported Week 52 Phase 3 results for sonelokimab: 67.2% of patients hit HiSCR75 and 33.1% reached HiSCR100, with no new safety signals.
For the roughly 1 in 100 people living with hidradenitis suppurativa, a chronic and often intensely painful skin disease marked by recurring abscesses, the condition has long had few treatments that work well. This week MoonLake Immunotherapeutics $MLTX reported Week 52 data from its Phase 3 VELA program testing the drug sonelokimab. Across the two trials, 67.2% of patients reached HiSCR75, the benchmark for a 75% reduction in abscess and inflammatory nodule count, while 33.1% reached HiSCR100, meaning no remaining abscesses or inflammatory nodules. Results were consistent across both studies, with 68.3% HiSCR75 in VELA-1 and 66.0% in VELA-2. About a quarter of patients, 26.0%, reached IHS4-100, a measure of inflammatory remission. Pain and daily life were also tracked. Nearly half of patients had at least a 3-point improvement on the worst skin pain scale, and the average quality-of-life score shifted from severe to mild impairment over the year. In an interim look at 22 adolescent patients at Week 24, about 68% reached HiSCR75. The company reported no new safety signals. According to MoonLake's announcement, clarity on the US regulatory review timeline is expected later this year alongside the FDA's acceptance of its application.