MoonLake Immunotherapeutics releases data from clinical trials of Nanobody SLK

In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index of 64% at week 16, and 39% of patients achieved a greater than or equal to75% reduction in the PPPASI, suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. The Company expects to commence a Phase 3 clinical trial in PPP in Q3 2026. In an interim analysis of long-term data from MoonLake’s Phase 3 clinical trials in adult patients with HS, the VELA-1 and VELA-2 trials, SLK demonstrates continuous clinical improvement and potentially competitive advantages beyond the week 16 primary endpoint. The Company confirmed a Type B meeting with the FDA, which is scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application. An interim analysis of the VELA-TEEN clinical trial, a Phase 3 study of SLK in adolescent HS patients, showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11). The trial is expected to enroll a total of 30-35 patients and topline results are expected to become available in 2026. The data is expected to be part of MoonLake’s BLA submission.