MoonLake Says Lead Drug Shows Durable Response, Eyes FDA Filing

MoonLake Immunotherapeutics (NASDAQ:MLTX) shares are volatile on Monday as the company is reporting long-term results from its VELA-1 and VELA-2 Phase 3 clinical trials of sonelokimab in patients with hidradenitis suppurativa (HS). HS is a chronic, non-contagious inflammatory skin condition, often called acne inversa, that causes painful, recurring lumps or abscesses, primarily in sweat gland areas like the armpits and groin. The data were presented at the 2026 American Academy of Dermatology Annual Meeting. Sonelokimab Shows Durable Lesion Response In the latest update on Saturday, MoonLake announced that 62% of patients treated with sonelokimab achieved a HiSCR75 response by Week 40, setting a new standard for long-term lesion control in HS. An analysis of different hallmark lesions of HS shows that up to 25% of patients achieved inflammatory remission at Week 40, defined as a 100% reduction in abscesses (A100), nodules (N100), and draining tunnels (DT100). Quality Of Life Metrics Improve Across Multiple Measures Sonelokimab-treated patients also showed substantial improvements in quality of life at week 40 versus baseline, ranging from 41% (pain) to 54% (walking, getting dressed) to 62% (down or depressed). Up to 43% of patients achieved at least a 3-point improvement from baseline in the worst skin pain NRS. Additionally, the safety profile of sonelokimab remains consistent, with no new safety signals detected during the VELA clinical trials. The company expects 52-week data from the VELA-1 and VELA-2 trials in HS in the second quarter of 2026. Regulatory Pathway And Upcoming Data Catalysts In January, MoonLake Immunotherapeutics received U.S. Food and Drug Administration (FDA) feedback regarding the clinical evidence strategy for sonelokimab (SLK) in HS, based on the Type B meeting requested by MoonLake. The FDA indicated that MoonLake may establish substantial evidence of effectiveness without additional clinical trials in HS. In addition, the FDA advised the company that the results of the VELA-2 trial should be submitted for the marketing application to inform the safety of SLK, regardless of decisions on its utility in establishing effectiveness. MoonLake will continue its planned preparations for BLA submission, which is on track for the second half of 2026. Axial Spondyloarthritis Study Results In February, MoonLake shared topline results from its Phase 2 clinical trial of sonelokimab in treating axial spondyloarthritis. In the Phase 2 S-OLARIS trial, 81% of patients treated with sonelokimab achieved a clinically meaningful response at Week 12, demonstrating significant improvement in key disease parameters. MLTX Price Action: MoonLake shares were down 2.57% at $16.87 at the time of publication on Monday, according to Benzinga Pro data. Image via Shutterstock