MoonLake Immunotherapeutics(US:MLTX) Globenewswire·2026-03-28 19:00Core Insights - MoonLake Immunotherapeutics announced long-term Week 40 results from the Phase 3 VELA-1 and VELA-2 clinical trials for sonelokimab (SLK) in patients with moderate-to-severe hidradenitis suppurativa (HS) [1][6] Group 1: Clinical Trial Results - The Phase 3 VELA program's primary endpoint was HiSCR 75, indicating a 75% reduction in abscess and inflammatory nodule count, with 838 patients enrolled across both trials [2][24] - At Week 40, 62% of patients treated with SLK achieved HiSCR75 response, and up to 32% achieved HiSCR100 response, demonstrating significant clinical efficacy [3][6] - Secondary endpoints showed that up to 77% of patients achieved an IHS-4 55 response, and 25% achieved inflammatory remission at Week 40 [3][6] Group 2: Quality of Life Improvements - Patients treated with SLK exhibited significant improvements in quality of life, with HiSQOL scores improving by -11.8 in VELA-1 and -12.4 in VELA-2 from baseline [5][6] - At baseline, 59% of patients were categorized as "very severe" on the HiSQOL severity score, which improved to 63% in the "mild / none" category by Week 40 [5][6] - Improvements in specific HiSQOL items ranged from 41% for pain to 62% for feelings of being down or depressed [5][6] Group 3: Safety Profile - The safety profile of SLK remained consistent over time, with no new safety signals detected in the VELA trials [8][6] - Discontinuation rates were low compared to other pivotal HS trials, indicating a favorable safety and tolerability profile [2][6] Group 4: Future Directions - Following Week 52, patients will have the option to switch into a two-year open-label extension trial, indicating ongoing commitment to long-term treatment evaluation [2][6] - Upcoming milestones include the submission of a Biologics License Application (BLA) for HS in H2 2026 and primary endpoint readouts for the Phase 3 IZAR trials in psoriatic arthritis [16][6]