– Using Ascletis’ proprietary Ultra-Long-Acting Platform technology, co-formulation of ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist and ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, demonstrated a comparable pharmacokinetic (PK) profile to ASC36 and ASC35 dosed alone in head-to-head non-human primate studies.
– ASC36 monotherapy demonstrated approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in a head-to-head diet-induced obese (DIO) rat study, while ASC35 monotherapy demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in a head-to-head DIO mouse study.
– Co-formulation of ASC36 and ASC35 demonstrated approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in a head-to-head DIO rat study.
– Co-formulation of ASC36 and ASC35 had excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.
– Submission of an Investigational New Drug Application to the U.S. Food and Drug Administration for co-formulation of ASC36 and ASC35 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 November 13, 2025.
HONG KONG, Nov. 12, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces the co-formulation of ASC36, a once-monthly next-generation amylin receptor agonist and ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for co-formulation of ASC36 and ASC35 for the treatment of obesity in the second quarter of 2026.
Both ASC36, a once-monthly next-generation amylin receptor agonist, and ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist, were discovered and developed in-house utilizing Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. Ascletis has successfully co-formulated ASC36 and ASC35 in the proprietary ultra-long-acting formulation to enable once monthly subcutaneous (SQ) administration using its ULAP technology. Co-formulation of ASC36 and ASC35 had excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH. Some of amylin receptor peptide agonists aggregate or precipitate at neutral pH, which leads to loss of potency, turbidity/particles, device clogging, and higher immunogenicity risk.
In head-to-head non-human primate (NHP) studies, co-formulation of ASC36 and ASC35 demonstrated a comparable pharmacokinetic profile to ASC36 and ASC35 dosed alone, supporting once-monthly SQ dosing.
ASC36 monotherapy demonstrated approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in a head-to-head diet-induced obese (DIO) rat study. ASC35 monotherapy demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in a head-to-head DIO mouse study (press release). The co-formulation of ASC36 and ASC35 demonstrated approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in a head-to-head DIO rat study (Table 1).
Table 1. ASC36 monotherapy and co-formulation of ASC36 and ASC35 demonstrated statistically and significantly more weight loss than eloralintide monotherapy and the co-formulation of eloralintide and tirzepatide in DIO rats after 7-day treatment
|
Group |
Dosing |
Total body weight change |
Greater relative weight |
|
Obese rats treated |
Vehicle, SQ, Q2D |
-0.5 % |
– |
|
Obese rats treated |
5 nmol/kg, SQ, Q2D |
-9.6% (p =0.028 vs eloralintide |
32% (vs eloralintide |
|
Obese rats treated |
5 nmol/kg, SQ, Q2D |
-7.3 % |
– |
|
Obese rats treated |
5 nmol/kg SQ, Q2D |
-14.5% (p |