HONG KONG, Oct. 2, 2026 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announced the presentation of key preclinical data for its ASC36_35FDC (ASC36_35 co-formulation) at the 62^nd European Association for the Study of Diabetes (EASD) Annual Meeting, being held September 28–October 2, 2026, in Milan, Italy (EASD 2026). ASC36_35FDC is a once-monthly to once-quarterly fixed-dose combination injection of ASC36, a peptide amylin receptor agonist, and ASC35, a peptide GLP-1R/GIPR agonist. The study was presented in a short oral discussion. The data demonstrated that ASC36_35FDC exhibited a greater weight-loss trend than eloralintide/tirzepatide or MET-233i/tirzepatide co-formulations in a diet-induced obesity (DIO) rat model, as well as excellent formulation stability. Furthermore, once-weekly oral tablet formulation of ASC36_35FDC has been developed by the Company.

Key Highlights

Robust Weight-Loss: Demonstrating Potential Synergistic Effects in Preclinical Models

In both DIO rat and non-human primate (NHP) models, ASC36_35FDC showed greater additional reductions in body weight and food intake compared with ASC35 monotherapy, suggesting a potential synergistic effect of the combination.

In the DIO rat model, ASC36_35FDC administered at 5 nmol/kg_8 nmol/kg once every two days for a total of seven doses demonstrated substantial weight-loss. On Day 14, under the same dosing regimen, body weight decreased by 12.5% with the eloralintide/tirzepatide co-formulation, 16.8% with the MET-233i/tirzepatide co-formulation, and 24.8% with ASC36_35FDC, a 98% and 47% greater relative reduction in body weight, respectively. Cumulative food intake was also substantially lower in the ASC36_35FDC group compared to the two comparator groups.

Excellent Chemical and Physical Stability: No Evidence of Fibrotic Aggregation

Long-term formulation stability is critical for peptide-based therapeutics. Under simulated storage conditions (200 rpm, 25°C, 168 hours), no fibril-induced aggregation was observed for ASC36_35FDC across different concentrations, vehicles, or pH conditions. In contrast, cagrilintide exhibited substantial fibrotic aggregation under the same conditions. These findings demonstrate the excellent chemical and physical stability of ASC36_35FDC and provide a strong foundation for further clinical development and potential large-scale manufacturing.

Pharmacokinetic Profile: Potential for Once-Monthly to Once-Quarterly Dosing

In NHPs, the pharmacokinetic (PK) profile of ASC36_35FDC was comparable to that observed following administration of ASC36 or ASC35 alone. The observed half-life of ASC36 and ASC35 demonstrated in ASC36_35FDC were as long as 781 hours(approximately 33 days) and 721 hours (approximately 30 days), respectively, supporting once-monthly and the potential for once-quarterly subcutaneous administration in humans. This ultra-long-acting profile has the potential to improve treatment convenience and patient adherence, offering a more convenient therapeutic approach for chronic weight management.

Summary and Outlook

ASC36_35FDC is an internally developed combination therapy leveraging Ascletis’ proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. By combining an amylin receptor agonist with a GLP-1R/GIPR dual agonist, ASC36_35FDC is designed to leverage the complementary effects of these two therapeutic mechanisms. The preliminary preclinical data demonstrate promising activity across body-weight reduction, appetite suppression, formulation stability, and pharmacokinetic properties, supporting the potential of ASC36_35FDC as a best-in-class therapeutic candidate.

About Ascletis Pharma Inc.

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potentially best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a once-daily oral small molecule GLP-1R agonist for chronic weight management and diabetes; ASC30_48FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC48 (GIPR agonist), ASC30_48_39FDC, a once-daily oral small molecule triple agonist, a fixed dose combination of ASC30 (GLP-1R agonist), ASC48 (GIPR agonist) and ASC39 (amylin receptor agonist (SARA)), ASC39, an eloralintide-like potent selective amylin receptor agonist (SARA) once-daily oral small molecule, ASC30_39FDC, a once-daily oral small molecule dual agonist, a fixed dose combination of ASC30 (GLP-1R agonist) and ASC39 (amylin receptor agonist (SARA)), ASC36, an amylin peptide, designed to be administered once monthly to once quarterly subcutaneously and once daily orally, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, ASC36_35FDC, a once-monthly subcutaneous triple peptide agonist, a fixed combination of ASC36 (amylin receptor agonist) and ASC35 (GLP-1R/GIPR agonist), ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, designed to be administered once monthly subcutaneously and once daily orally, and ASC36_37FDC, a once-monthly subcutaneous quadruple peptide agonist, a fixed dose combination of ASC36 (amylin receptor agonist) and ASC37 (GLP-1R/GIPR/GCGR agonist), for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).

For more information, please visit www.ascletis.com. 

Contact:
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com

Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com 

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SOURCE Ascletis Pharma Inc.