Ascletis Announces Ultra-Long-Acting Subcutaneous Depot Maintenance Formulation of Small Molecule GLP-1R Agonist ASC30 Demonstrated an Observed Half-Life of 75 Days in Participants with Obesity

Core Insights - Ascletis Pharma Inc. announced that its ultra-long-acting subcutaneous (SQ) depot formulation of the small molecule GLP-1 receptor agonist ASC30 demonstrated a 75-day observed half-life in a Phase Ib clinical study, supporting once-quarterly administration for chronic weight management [3][4][5]. Group 1: Clinical Study Results - The Phase Ib study involved participants with obesity (BMI ≥ 30 kg/m²) and showed that after a single SQ injection of ASC30 (100 mg), the median time to reach maximum concentration (Cmax) was 17 days, with a half-life of approximately 75 days [4][6]. - The study reported no serious adverse events (SAEs) and only mild gastrointestinal-related adverse events among ASC30-treated participants, indicating a favorable safety profile [6][9]. Group 2: Market Potential and Therapeutic Need - ASC30 is positioned as the most clinically advanced once-quarterly incretin drug, addressing a significant unmet medical need for maintenance therapy in chronic weight management [2][5]. - The drug's pharmacokinetic profile, including its ultra-long half-life, is expected to enhance patient compliance and quality of life by allowing for less frequent dosing compared to existing therapies [5][11]. Group 3: Development and Future Prospects - Ascletis is also investigating ASC30 as a once-monthly treatment therapy in a Phase IIa study, with topline data expected in the first quarter of 2026 [11]. - The company utilizes its proprietary Ultra-Long-Acting Platform (ULAP) technology to develop ASC30, which is designed for both oral and subcutaneous administration, indicating a versatile approach to treatment [12][14].