At the one-year mark of MoonLake’s Phase 3 VELA program, 67.2% of adults treated with sonelokimab achieved HiSCR75, and a third reached HiSCR100, complete skin-lesion clearance by a demanding composite measure. Those numbers matter not just as clinical outcomes but as a direct challenge to an HS market that already has two approved IL-17 inhibitors: Novartis’s secukinumab, approved for adults in October 2023, and UCB’s bimekizumab, cleared for adults in November 2024 as the first approved agent to inhibit both IL-17A and IL-17F. Sonelokimab is also a dual IL-17A and IL-17F inhibitor, delivered as a Nanobody, and MoonLake is openly benchmarking its trial results against those prior programs using pooled, as-observed, end-of-parental-trial methodology, claiming more than ten percentage points of separation on HiSCR75, HiSCR100, and inflammatory remission rates relative to the competing IL-17A/F monoclonal antibody.
The depth of response data reinforces the efficacy story. A quarter of the 396 treated patients hit IHS4-100, full inflammatory remission across abscesses, nodules, and draining tunnels. Nearly half reported a clinically meaningful pain reduction of at least three NRS points. Quality-of-life scores shifted on average from the severe to the mild range on the HS-specific HiSQOL instrument. The placebo-crossover arm adds structural credibility: patients who switched to sonelokimab at Week 16 gained roughly 20 percentage points in HiSCR75 within four weeks, and by 36 weeks of active treatment their response rates converged with the original treatment arm at around 60%. That convergence suggests the drug’s effect is tied to duration of exposure, not to baseline selection. A roughly 90% rollover rate into the two-year open-label extension reinforces tolerability and patient acceptance of the once-every-four-weeks dosing schedule.
The adolescent data in VELA-TEEN add a strategic dimension. Interim Week 24 results in 22 patients showed about 68% reaching HiSCR75 and 45% reaching HiSCR100, rates that outpaced the adult program at comparable timepoints. MoonLake’s argument is that earlier intervention in adolescents may interrupt the progression to irreversible fibrotic tissue damage. Secukinumab’s March 2026 approval for patients aged 12 and older means this is already a contested space, and any pediatric label for sonelokimab will compete directly in that population. MoonLake plans BLA submission including the adolescent data by the end of September 2026.
The single number to track from here is the September 2026 BLA submission date. A complete, on-time filing that incorporates both the adult Week 52 package and the VELA-TEEN data without a major amendment request would validate MoonLake’s regulatory confidence and put the FDA review clock in motion before any further competitive approvals can reset the differentiation narrative.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
