MoonLake Immunotherapeutics: Second Late-Stage Program Moves Sonelokimab Forward

Core Insights - MoonLake Immunotherapeutics has made significant progress in developing sonelokimab for moderate-to-severe hidradenitis suppurativa (HS), having received positive feedback from both the FDA and EMA to advance to late-stage clinical testing with the initiation of the phase 3 VELA program [1][3] - The VELA program includes two phase 3 studies, VELA-1 and VELA-2, both utilizing the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR)75, with a notable delta difference of 29 compared to placebo at a 120 mg dose, achieving statistical significance (p=0.0002) [1][6] - The company is also advancing the IZAR program for treating psoriatic arthritis (PsA), with the first patient expected to be dosed in Q4 2024 and primary endpoint data readout anticipated by the end of 2026 [3][7] Development Programs - The VELA program aims to evaluate sonelokimab in HS patients over a 52-week period, with the primary endpoint assessed at 16 weeks, and results expected by mid-2025 [6][7] - The IZAR program will consist of two studies, IZAR-1 and IZAR-2, targeting biologic-naive and TNF inhibitor refractory patients, respectively, with a total of 1,500 patients planned for treatment [7][8] - Sonelokimab has shown versatility, with plans to initiate additional studies for juvenile HS and palmoplantar pustulosis (PPP) in 2024 [3][7] Competitive Landscape - Sonelokimab is positioned against existing biologics like Humira and Cosentyx, which have been approved for HS and PsA, but MoonLake aims to leverage the more stringent HiSCR75 endpoint to demonstrate superior efficacy [6][7] - The drug's unique mechanism targets both IL-17A and IL-17F, potentially offering a competitive advantage over other treatments that do not target these cytokines as effectively [6][7] Financial Position - As of March 31, 2024, MoonLake had cash and equivalents totaling $547.1 million, bolstered by financial transactions in 2023, including a sales agreement that generated$52.5 million from the sale of Class A Ordinary Shares [8] - The company has a cash burn rate of $19.8 million per quarter, indicating a sufficient cash runway to support operations through the end of 2026 [8]