MoonLake Immunotherapeutics Announces Positive Regulatory Feedback from both FDA and EMA on Path for the Phase 3 Program for the Nanobody® sonelokimab in Psoriatic Arthritis

Core Insights - MoonLake Immunotherapeutics has received positive regulatory feedback from both the FDA and EMA for its Phase 3 program of sonelokimab in psoriatic arthritis (PsA) [1][4][17] - The Phase 3 program, named IZAR, will enroll approximately 1,500 patients and includes two trials: IZAR-1 for biologic-naïve patients and IZAR-2 for TNF-IR patients [1][4][5] - The primary endpoint for both trials is the ACR 50 response at Week 16, with results expected by the end of 2026 [4][5][22] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases, particularly hidradenitis suppurativa (HS) and psoriatic arthritis [32] - The company was founded in 2021 and is headquartered in Zug, Switzerland [32] - Sonelokimab is a novel investigational Nanobody® that inhibits IL-17A and IL-17F, which are key drivers of inflammation in these diseases [32] Psoriatic Arthritis (PsA) Insights - PsA is a chronic inflammatory arthritis that affects up to 30% of patients with psoriasis, primarily impacting individuals aged 30 to 60 [2][18] - The disease is characterized by joint pain, swelling, and stiffness, significantly affecting patients' quality of life [2][18] - The IL-17 pathway is believed to play a crucial role in the pathophysiology of PsA [2] Clinical Trial Details - The IZAR program will consist of two global, randomized, double-blind, placebo-controlled trials: IZAR-1 and IZAR-2 [4][5] - IZAR-1 will focus on biologic-naïve patients and assess radiographic progression, while IZAR-2 will include a risankizumab active reference arm for TNF-IR patients [4][5] - The primary endpoint for both trials is the ACR 50 response, with secondary endpoints reflecting various disease manifestations [5][20] Hidradenitis Suppurativa (HS) Insights - HS is a chronic skin condition affecting 0.05–4.1% of the global population, with a significant unmet need for effective treatments [12] - The condition leads to painful inflammatory lesions and can result in irreversible tissue destruction [12] - MoonLake is also conducting Phase 3 trials for sonelokimab in HS, following positive outcomes from earlier trials [7][21]