-In head-to-head non-human primate (NHP) studies, average observed half-life of ASC36 was approximately 15 days, 3-fold longer than petrelintide, which supports once-monthly subcutaneous (SQ) dosing in humans.
-ASC36 demonstrated approximately 91% greater relative body weight reduction compared to petrelintide in a head-to-head diet-induced obese (DIO) rat study.
-ASC36 has excellent chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation with other peptides including ASC35, a GLP-1R/GIPR dual agonist.
-Submission of an Investigational New Drug Application (IND) for ASC36 to the U.S. Food and Drug Administration (FDA) is expected in the second quarter of 2026.
-The Company will host a conference call in Mandarin at 10:00 a.m. China Standard Time on October 30, 2025.
HONG KONG, Oct. 29, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces that it has selected ASC36, a once-monthly, potentially best-in-class subcutaneously administered amylin receptor agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) for ASC36 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026.
ASC36, an amylin receptor peptide agonist, was discovered and developed in-house utilizing Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. ASC36 is engineered for a longer observed half-life (as measured by time to 50% Cmax) and higher bioavailability per milligram of peptide to support once-monthly subcutaneous (SQ) dosing, with injection volume of one milliliter or less. These engineered properties also allow for scalability advantages in manufacturing.
In head-to-head non-human primate (NHP) studies, ASC36 slow-release SQ depot formulations had an average observed half-life of approximately 15 days, 3-fold longer than petrelintide, supporting ASC36 as a potential once-monthly treatment for obesity in humans.
In a head-to-head diet-induced obese (DIO) rat study, which is well established as being highly predictive of human efficacy, dosed with equal molar concentrations of ASC36 and petrelintide, ASC36 reduced body weight by 10.01%, compared to 5.25% for petrelintide, a relative increase in efficacy of 91% (Table 1). This superior weight loss per milligram of peptide may also provide scalability advantages in manufacturing.
Table 1. ASC36 demonstrated statistically and significantly more weight loss than petrelintide in DIO rats after 7-day treatment
|
Group |
Dosing |
Total body weight change from baseline |
Greater relative weight loss versus petrelintide |
|
Obese rats treated with vehicle |
Vehicle, SQ, Q2D |
1.05 % |
– |
|
Obese rats treated with ASC36 |
10 nmol/kg, SQ, Q2D |
-10.01% (p |