MoonLake to Submit BLA for Sonelokimab in Hidradenitis Suppurativa Following Successful Phase 3 VELA Trial

▎Armstrong

On June 21, 2026, Moonlake announced the 52-week Phase III clinical trial VELA data for sonelokimab, an IL-17A/F nanobody bispecific antibody, in the treatment of hidradenitis suppurativa. The data showed that after 52 weeks of treatment, 67.2% of patients achieved HiSCR75, and 33.1% achieved HiSCR100 (VELA-1:68.3% HiSCR75, 31.2% HiSCR100; VELA-2: 66.0% HiSCR75, 35.1% HiSCR100). After 52 weeks of treatment, 26.0% of patients achieved IHS4-100 (reflecting complete resolution of inflammation), with rates of 24.4% in VELA-1 and 27.7% in VELA-2. Interim data disclosed last September,The HiSCR rates at 16 weeks of sonelokimab treatment were 17.3% and 10.3%, respectively, and the HiSCR50 rates were 21.3% and 15.7%, respectively. The updated long-term data demonstrate a continued deepening of efficacy.

Moonlake plans to file its listing application this September, with the PDUFA date expected in November 2026.

Sonelokimab demonstrates superior efficacy in HS compared to competitors (non-head-to-head).

Sonelokimab can simultaneously inhibit IL-17A/A, IL-17A/F, and IL-17F/F dimers.

Preclinical studies indicate that sonelokimab, in its nanobody format, exhibits superior efficacy in targeting deep-tissue inflammation compared to conventional antibodies, owing to its lower molecular weight.

Sonelokimab is also being explored for multiple indications, including hidradenitis suppurativa, psoriatic arthritis, and psoriasis.

Summary

In the iterative development of Th17 pathway therapeutics, including nanobodies, oral cyclic peptides, and small molecules, Johnson & Johnson/Protagonist’s IL-23R oral cyclic peptide has already been approved for market launch, while Lilly’s IL-17 small molecule remains under clinical exploration, and Moonlake’s IL-17 bispecific nanobody is poised to submit its marketing application.