Company: MLTX
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001821586-25-000006
Chunk: 25

Company: MoonLake Immunotherapeutics
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 25
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 primary endpoint is the 

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MOONLAKE IMMUNOTHERAPEUTICSFORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2024PART I

percentage of participants achieving HiSCR75. The trials will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in IHS4, the proportion of patients achieving a DLQI total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale in the PGA Skin Pain and complete resolution of Draining Tunnels. 

From week 16, all patients will receive the 120mg dose of SLK through to 52 weeks, followed by an open-label extension for up to two years (Figure 3). The VELA program will use a protocol design consistent with the Phase 2 MIRA trial, which identified the optimal dose of SLK for HS. The topline primary endpoint readout (week 16) from the VELA program is expected as of mid-2025.

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Figure 3 — Design of the Phase 3 VELA program in HS.

Phase 3 Clinical Trial in Adolescent HS: VELA-TEEN

The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate SLK 120mg administered subcutaneously once every two weeks until week six and once every four weeks from week eight onwards. The trial aims to enroll 35 adolescents, aged 12-17, with moderate-to-severe HS, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of SLK. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the HiSCR75, in addition to HiSCR50. Other outcomes are the change from baseline in the IHS4, which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the CDLQI and the PGA Skin Pain. Topline data for the primary and secondary endpoints, including the higher clinical response level of HiSCR75, are anticipated in 2026.

Phase 2b Clinical Trial in PsA: the ARGO Trial

The ARGO trial is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and