MoonLake Immunotherapeutics (Nasdaq: MLTX) reported Week 40 data from its Phase III VELA program evaluating sonelokimab in hidradenitis suppurativa, showing continued improvement in clinical responses beyond the Week 16 primary endpoint, with 62% of treated patients achieving HiSCR75 and up to 32% reaching complete clinical response as measured by HiSCR100.
The VELA Program and Trial Design
The VELA-1 and VELA-2 trials are identical, global, randomized, double-blind, placebo-controlled Phase III studies that enrolled a combined 838 adults with moderate-to-severe HS. Both trials used HiSCR75 — defined as at least a 75% reduction in abscess and inflammatory nodule count with no increase in abscess or draining tunnel count — as the primary endpoint at Week 16. Following the primary readout, placebo patients switched to sonelokimab, while those originally randomized to the active arm continued on the monthly 120mg maintenance dose. All patients have now completed Week 40, with a final assessment planned at Week 52.
Sonelokimab HS Results at Week 40
The Week 40 data, presented at AAD 2026 by MoonLake investigator Prof. Alexa Kimball of Harvard Medical School, showed consistent responses across both studies. In VELA-1, 61.9% of sonelokimab-treated patients achieved HiSCR75 and 32.4% achieved HiSCR100. In VELA-2, those figures were 61.8% and 28.1%, respectively. These are as-observed analyses, meaning they do not impute data for patients who discontinued.
Beyond the headline lesion counts, MoonLake reported that up to 77% of patients achieved an IHS4-55 response — a 55% or greater reduction in the International HS Severity Scoring System — and up to 25% reached what the company defined as inflammatory remission: complete resolution of abscesses, nodules, and draining tunnels simultaneously. Discontinuation rates were described as at the low end compared to other HS pivotal programs, though MoonLake did not disclose exact figures.
Patient-Reported Outcomes Tell a Parallel Story
The VELA clinical trial results also included a range of patient-reported outcome measures that tracked quality of life changes from baseline to Week 40. Mean HiSQOL scores — a validated HS-specific quality of life instrument — improved by 11.8 points in VELA-1 and 12.4 points in VELA-2 from baselines of 26.5 and 28.0, respectively. At baseline, 59% of patients fell into the "very severe" HiSQOL category; by Week 40, 63% had shifted to "mild or none."
Functional improvements were also recorded across individual HiSQOL-Mini items, with reductions ranging from 41% for pain to 54% for mobility-related tasks such as walking and getting dressed, and 62% for depressive symptoms. Up to 43% of patients with baseline worst skin pain scores of at least three points achieved a clinically meaningful three-point or greater reduction on the numerical rating scale. Separately, 65% of patients with baseline DLQI scores of four or higher achieved at least a four-point improvement — the threshold considered the minimal clinically important difference for that instrument.
Safety Profile Holds Steady
No new safety signals were detected through Week 40 in either VELA trial. The safety profile remained consistent with what had been observed in earlier studies of sonelokimab, including the Phase II MIRA trial in HS and the Phase IIb psoriasis study. MoonLake did not disclose specific adverse event rates or breakdowns in the press release.