MoonLake reports Week 40 results from Phase 3 sonelokimab trials in hidradenitis suppurativa

MoonLake presented Week 40 data from its Phase 3 VELA-1 and VELA-2 trials of sonelokimab in adults with moderate-to-severe hidradenitis suppurativa, reporting 62% HiSCR75 and up to 32% HiSCR100 responses (as observed). The company reported improved patient-reported outcomes and a safety profile consistent with prior data, with no new safety signals detected.

MoonLake Immunotherapeutics released Week 40 results from its Phase 3 VELA-1 and VELA-2 trials of sonelokimab in adults with moderate-to-severe hidradenitis suppurativa. The trials enrolled a total of 838 patients and used the higher HiSCR75 threshold as the primary endpoint. After the Week 16 primary readout, placebo patients were switched to sonelokimab and all participants completed Week 40. The Week 40 findings were presented at the 2026 American Academy of Dermatology Annual Meeting. Key findings: - 62% of patients treated with sonelokimab achieved a HiSCR75 response at Week 40 (as observed) across both VELA-1 and VELA-2. - Up to 32% of patients achieved HiSCR100 at Week 40 (VELA-1: 32.4%, VELA-2: 28.1%; as observed). - Up to 77% of patients achieved an IHS4-55 response, and up to 25% reached inflammatory remission at Week 40 (as observed). - Patient-reported outcomes improved: HiSQOL change from baseline was -11.8 in VELA-1 and -12.4 in VELA-2, and 65% of patients achieved a DLQI improvement of at least four points (as observed). - The safety profile remained consistent over time with no new safety signals detected. Summary: The Week 40 results indicate sustained clinical responses and measurable improvements in patient-reported outcomes in the VELA program. Safety findings were consistent with prior trial reports. Participants remain in the trials through Week 52, after which they may enter a two-year open-label extension. Additional regulatory or milestone timing was not specified in this release.