MoonLake initiates three new clinical trials and further expands the portfolio of indications for the Nanobody® sonelokimab

Core Insights - MoonLake Immunotherapeutics has initiated three new clinical trials for sonelokimab, targeting adolescent hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP), and axial spondyloarthritis (axSpA), expanding its clinical program to ten trials [1][4][20] - The company aims to enroll over 3,000 patients in clinical trials since its founding in 2021, with significant data readouts expected in 2025 and 2026 [1][4][9] - The market for HS is projected to reach $15 billion by 2035, highlighting the potential commercial opportunity for sonelokimab [3][13] Company Developments - The Phase 3 VELA-TEEN trial is the first dedicated clinical trial for adolescent patients with moderate-to-severe HS, while the Phase 2 LEDA trial focuses on PPP and the Phase 2 S-OLARIS trial on axSpA [4][6][12] - Sonelokimab is designed to inhibit IL-17A and IL-17F, targeting inflammation in difficult-to-reach tissues, which is crucial for the pathophysiology of these diseases [2][19] - The company has a robust cash position and is progressing towards registration and commercialization of sonelokimab [3][4] Clinical Trial Insights - The VELA-TEEN trial will evaluate the pharmacokinetics, safety, and tolerability of sonelokimab in adolescents aged 12-17 with HS, with a primary endpoint over 24 weeks [5][12] - The LEDA trial aims to assess the efficacy and safety of sonelokimab in adult patients with PPP, focusing on the percent change in the Palmoplantar Psoriasis Area and Severity Index (ppPASI) [10][16] - The S-OLARIS trial will combine traditional clinical outcomes with PET/MRI imaging to evaluate sonelokimab's impact on axSpA [11][14] Market Context - HS affects approximately 2% of the population, with significant unmet medical needs, particularly in adolescents [5][13] - PPP is a chronic condition with limited treatment options, emphasizing the need for innovative therapies like sonelokimab [7][18] - AxSpA has a global prevalence of 0.5% to 1.5%, with many patients experiencing inadequate responses to current therapies, indicating a demand for new treatment approaches [8][15]