MoonLake Immunotherapeutics announces results from Phase 3 VELA-1, VELA-2 trial

MoonLake Immunotherapeutics (MLTX) announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology, AAD, Annual Meeting later. The Phase 3 VELA program in adults with moderate-to-severe HS used the higher clinical response level of HS Clinical Response 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. Key secondary endpoints included the change from baseline in the HS Quality of Life score as well as other scores that reflect the evolving needs of HS patients, treating physicians and regulators. These included the percentage of participants achieving at least a 55% reduction in the International HS Severity Scoring System, the percentage of participants achieving at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale among participants with a baseline score of at least 3 points, and the percentage of patients achieving a Dermatology Quality of Life Index total score improvement of greater than or equal to4, among participants with a baseline DLQI greater than or equal to4. A total of 838 patients were enrolled across both trials. Following the primary endpoint at Week 16, patients in the placebo arm were switched to receive SLK treatment for the remaining duration of the trial until Week 52. Patients originally randomized to the SLK arm continued to receive SLK at the monthly 120mg maintenance dose. All patients have completed Week 40 and discontinuation rates were at the low end to those observed in other pivotal HS trials. After Week 52, patients have the opportunity to switch into a two-year open-label extension trial.