Ardmore Shipping(US:ASC) Prnewswireยท2025-11-12 23:30Core 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]