MoonLake Immunotherapeutics Receives Positive FDA and EMA Feedback for Phase 3 Sonelokimab in Psoriatic Arthritis

MoonLake Immunotherapeutics, a clinical-stage biotechnology company, has achieved significant regulatory milestones with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advancing its Phase 3 clinical program of the Nanobody® sonelokimab in treating psoriatic arthritis (PsA). This progress builds upon previously received positive feedback for sonelokimab's Phase 3 VELA program targeting hidradenitis suppurativa (HS).

The planned Phase 3 program, named IZAR, will consist of two global, randomized, double-blind, placebo-controlled trials: IZAR-1 and IZAR-2. IZAR-1 will focus on biologic-naïve patients and include an assessment of radiographic progression, while IZAR-2 will target TNF-inhibitor-experienced patients and incorporate a risankizumab active reference arm. The primary dose to be tested is 60mg, with an additional evaluation for a 120mg dose. The trials will collectively enroll approximately 1,500 participants, leveraging Phase 2 data from the ARGO trial for registration purposes.

The Phase 3 trials are designed to evaluate sonelokimab's efficacy and safety over a year, with primary and key secondary endpoint readouts expected at Week 16. MoonLake aims to randomize the first patient by Q4 2024, with primary endpoint results anticipated by the end of 2026.

Dr. Jorge Santos da Silva, CEO of MoonLake Immunotherapeutics, emphasized the significance of these regulatory achievements, marking the company's sustained commitment to addressing underserved inflammatory conditions. Psoriatic arthritis is a chronic inflammatory disease linked to psoriasis, affecting up to 30% of psoriasis patients. It involves joint pain, swelling, stiffness, and can lead to restricted mobility and significant fatigue. Current evidence suggests that PsA pathophysiology is closely related to IL-17 pathway activation.

Sonelokimab, an investigational Nanobody® with three VHH domains, selectively binds to IL-17A and IL-17F, inhibiting inflammatory processes. Apart from PsA, sonelokimab is being assessed for HS, with earlier trial phases showing promising results. The MIRA trial demonstrated significant clinical responses, paving the way for Phase 3 assessments, which began after favorable regulatory reviews.

For PS, the Phase 3 initiation is projected for late 2024 following positive Phase 2 ARGO trial outcomes, which showed notable improvements in key clinical measures over 24 weeks. MoonLake also plans Phase 2 trials for other indications, including palmo-plantar pustulosis and juvenile HS, reflecting the company's broader strategy to explore sonelokimab's potential in various inflammatory conditions.

Nanobodies®, derived from antibody variable regions, offer several advantages such as enhanced tissue penetration and ease of manufacturing. These features make Nanobodies® a promising class of therapeutic molecules for targeted treatments.

MoonLake’s continued progress underscores its expertise in inflammation and immunology, aiming to bring next-level therapies to patients with significant unmet medical needs.

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