Highlights
- Once-monthly co-formulation of amylin receptor agonist ASC36 and dual GLP-1R/GIPR agonist ASC35 developed using Ascletis’ Ultra-Long-Acting Platform (ULAP).
- 51% greater body weight reduction compared to the co-formulation of eloralintide and tirzepatide in DIO rat studies.
- Stable formulation with no aggregation or precipitation at neutral pH.
- IND submission to the U.S. FDA expected in Q2 2026.
Co-Formulation Achieves Robust Efficacy and Stability
Ascletis Pharma Inc. (HKEX: 1672) announced the successful co-formulation of ASC36, a once-monthly amylin receptor agonist, and ASC35, a once-monthly GLP-1R/GIPR dual agonist. The combination was developed using Ascletis’ proprietary Ultra-Long-Acting Platform (ULAP) technology.
In head-to-head non-human primate studies, the co-formulation demonstrated a comparable pharmacokinetic (PK) profile to ASC36 and ASC35 when dosed individually, supporting once-monthly subcutaneous administration.
Further, the co-formulation showed excellent chemical and physical stability, with no aggregation or fibrillation at neutral pH—addressing a common issue seen in amylin receptor peptide agonists that can reduce potency and increase immunogenicity risk.
Significant Weight Reduction in Preclinical Models
In preclinical diet-induced obese (DIO) animal studies:
- ASC36 monotherapy reduced body weight 32% more than eloralintide in DIO rats.
- ASC35 monotherapy achieved 71% greater body weight reduction than tirzepatide in DIO mice.
- Co-formulation of ASC36 and ASC35 resulted in 51% greater weight loss compared to the co-formulation of eloralintide and tirzepatide in DIO rats.
|
Treatement Group |
Dosing |
Weight Change from Baseline |
Relative Weight Loss |
|
Vehical |
SQ, Q2D |
-0.5% |
- |
|
ASC35 Monotherapy |
5nmol/kg, SQ, Q2D |
-9.6% (p=0.028 vs eloralintide) |
+32% |
|
Eloralintide Monotherapy |
5 nmol/kg, SQ, Q2D |
-7.3% |
- |
|
ASC36 + ASC35 co-formulation |
5 nmol/kg, SQ, Q2D |
-14.5% (p<0.0001 vs eloralintide % elarolintide+tirzepatide) |
+51% |
|
Eloralintide + Tirzepatide co-formulation |
5 nmol/kg + 8 nmol/kg, SQ, Q2D |
-9.6% |
- |
“These encouraging data suggest our ASC36–ASC35 co-formulation could deliver greater weight loss in people with obesity than single-agent therapies,” said Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis. “Our ULAP and AI-assisted drug design platforms are enabling a new generation of once-monthly peptide therapies.”
Platform-Driven Peptide Innovation
Both ASC36 and ASC35 were discovered and developed in-house using Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and ULAP technologies. ULAP allows precise control of peptide release rates in subcutaneous depots, minimizing peak-to-trough variations and improving tolerability.
Ascletis plans to file an Investigational New Drug (IND) application with the U.S. FDA for the co-formulation in Q2 2026.
ASC36: The Cornerstone of Monthly Obesity Therapies
Ascletis is positioning ASC36 as a foundational component of its cardio-metabolic disease portfolio, targeting obesity and related disorders. In addition to its combination with ASC35, the company is evaluating co-formulation opportunities with ASC47, an adipose-targeted thyroid hormone receptor beta (THRβ) agonist.
Conference Call
Ascletis will host a conference call in Mandarin on November 13, 2025, at 10:00 a.m. China Standard Time via Tencent Meeting/VooV Meeting.
- Meeting ID: 573-120-481
- China Mainland: Tencent Meeting Link
- International: VooV Meeting Link
About Ascletis Pharma Inc.
Ascletis Pharma Inc. (HKEX: 1672) is a fully integrated biotechnology company focused on developing first-in-class and best-in-class therapeutics for metabolic diseases. Leveraging AISBDD and ULAP technologies, Ascletis has built a diverse in-house pipeline of small molecules and peptides, including:
- ASC30: Small-molecule GLP-1R agonist (oral and subcutaneous formulations)
- ASC35: Once-monthly GLP-1R/GIPR dual peptide agonist
- ASC36: Once-monthly amylin receptor peptide agonist
