Company: MLTX
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001821586-25-000006
Chunk: 29

Company: MoonLake Immunotherapeutics
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 29
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 — Design of the Phase 3 IZAR program in PsA.

Additional Phase 2 Clinical Trial in PsA: The P-OLARIS Trial

The P-OLARIS trial is an open-label imaging Phase 2 trial designed to explore the effects of SLK 60mg administered subcutaneously in 30 patients with seronegative spondyloarthritis which includes PsA. The primary endpoint is the change from baseline (CfB) in [68Ga]-FAPI-46 SUVmax signal per lesion at Week 12, as detected by FAPI-PET/low-dose CT scan. In addition, several other endpoints will be assessed including clinical disease activity scores and patient-related outcomes. The trial also features a peripheral blood and tissue biomarker program. We expect the P-OLARIS trial to provide a more complete picture of SLK's benefit in patients with active PsA and thereby more clearly differentiate SLK, a Nanobody, from monoclonal antibody-based treatment options, including other IL-17A and IL-17F inhibitors. We expect to start enrollment of patients in the first half of 2025 and the topline primary endpoint readout in the first half of 2026.

Phase 2 Clinical Trial in PPP: The LEDA Trial

The LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of SLK 120mg administered subcutaneously in adult patients with PPP. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls.

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

The trial design has been informed by previous successful studies of SLK, including the landmark Phase 2 MIRA trial in HS, which identified the optimal dosing and demonstrated the potential of SLK to target deep tissue inflammation effectively. The topline primary endpoint readout is expected during 2025.

Phase 2 Clinical Trial in axSpA: the S-OLARIS Trial

The S-OLARIS trial is an open-label imaging Phase 2 proof-of-concept trial aiming to investigate SLK 60mg administered subcut