Core Insights - Ascletis Pharma Inc. has announced the co-formulation of ASC36, a once-monthly amylin receptor agonist, and ASC35, a once-monthly GLP-1R/GIPR dual agonist, for clinical development targeting obesity [5][6] Pharmacokinetics and Efficacy - The co-formulation of ASC36 and ASC35 demonstrated a comparable pharmacokinetic profile to the individual dosing of ASC36 and ASC35 in non-human primate studies, supporting once-monthly subcutaneous administration [7] - ASC36 monotherapy showed approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in diet-induced obese (DIO) rat studies, while ASC35 monotherapy exhibited approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in DIO mouse studies [2][8] - The co-formulation of ASC36 and ASC35 resulted in approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in DIO rat studies [3][9] Stability and Formulation - The co-formulation of ASC36 and ASC35 exhibited excellent chemical and physical stability, with no aggregation or precipitation at neutral pH, which is crucial for maintaining potency and reducing immunogenicity risks [6][3] Regulatory and Future Plans - The company plans to submit an Investigational New Drug Application (IND) to the U.S. FDA for the co-formulation of ASC36 and ASC35 in the second quarter of 2026 [4][5] - A conference call is scheduled for November 13, 2025, to discuss further developments [12] Technological Advancements - Ascletis utilized its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies to develop ASC36 and ASC35, enabling the design of multiple once-monthly subcutaneous ultra-long-acting peptides [6][11]

Core Insights - Ascletis Pharma Inc. has initiated a 12-week Phase IIa study in the U.S. for its once-monthly subcutaneous (SQ) depot formulation of the small molecule GLP-1 receptor agonist ASC30, targeting participants with obesity or overweight and at least one weight-related comorbidity [3][6] - The ASC30 formulation has demonstrated a 36-day half-life in a Phase Ib study, supporting its monthly administration [4][5] - Topline data from the Phase IIa study is expected in the first quarter of 2026 [2][6] Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP) [9][10] - ASC30 is a unique investigational GLP-1R biased small molecule agonist that can be administered both orally and subcutaneously, with patent protection until 2044 [8][10] Study Details - The Phase IIa study is randomized, double-blind, placebo-controlled, and multi-center, involving approximately 65 participants with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m² but < 30 kg/m²) [6] - The study consists of three cohorts with different doses to evaluate safety, tolerability, and efficacy [6] Technical Insights - The ultra-long-acting SQ depot formulation of ASC30 has a peak-to-trough ratio of less than 2:1, which is critical for achieving acceptable tolerability for SQ dosing of incretin drugs [2][5] - ASC30 is the only once-a-month incretin in clinical development with a half-life greater than the intended dosing interval, which is essential for optimal tolerability [5]