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HONG KONG, June 8, 2026 /PRNewswire/ — Ascletis Pharma Inc. (HKEx: 1672, “Ascletis”) today announced that three of its key studies were presented at the American Diabetes Association (ADA) 2026 Scientific Sessions (June 5-8, 2026, New Orleans, Louisiana), highlighting its differentiated product pipeline in obesity treatment, including small molecule drug candidates, a peptide drug, and an oral peptide delivery enhancement technology. The data garnered significant attention from conference experts and further underscored Ascletis’ innovative capabilities in metabolic disease therapies.
Key Data
1. Potent Oral Amylin Receptor Agonist: ASC39
In vitro studies showed that ASC39’s selectivity for the human amylin type 1 receptor (hAMY1R) is comparable to that of eloralintide, and its affinity for the amylin receptor is significantly higher than its affinity for the human calcitonin receptor (hCTR). This receptor selectivity may help minimize central adverse effects mediated by the calcitonin receptor, such as nausea and excessive appetite suppression.
In a diet-induced obesity (DIO) rat model, ASC39 was administered orally once daily at doses of 0.2 mg/kg, 1 mg/kg, and 5 mg/kg. A clear dose-dependent weight loss was observed. On Day 11, animals treated with 5 mg/kg ASC39 showed a 9.9% reduction in body weight from baseline, compared to a 2.8% reduction in the placebo group (p < 0.01).
In another head-to-head DIO rat study, ASC39 (5 mg/kg, oral, once daily) was compared with eloralintide (3 nmol/kg, subcutaneous, every three days). Both drugs began to induce weight loss from Day 2 after the start of dosing. By Day 7, body weight in the ASC39 and eloralintide groups decreased by 6.0% (p < 0.0001) and 5.0% (p < 0.0001) from baseline, respectively, while the placebo group saw a 0.6% increase.
Key Conclusions
These findings indicate that ASC39 is a highly selective and potent oral small molecule amylin receptor agonist, with potential for development as a candidate drug for treating obesity.
2. Oral Small Molecule GLP-1 Receptor Agonist: ASC30
ASC30 is an oral small molecule glucagon-like peptide-1 receptor (GLP-1R) fully biased agonist with a chemical scaffold similar to orforglipron (OFG). In vitro studies showed that ASC30 is approximately 2 to 3 times more potent than OFG. In non-human primates, a 1.5 mg/kg dose of ASC30 stimulated significantly higher insulin secretion than a 6 mg/kg dose of OFG, with statistical significance. In a non-human primate study, the oral exposure of ASC30 was approximately 5 times that of OFG. In obese subjects, ASC30 demonstrated dose-proportional pharmacokinetics across a 2 mg to 60 mg dose range, with a peak-to-trough ratio below 2:1. In a 4-week Phase I study, ASC30 showed good safety and tolerability across all dose groups (20 mg, 40 mg, and 60 mg), with no liver safety signals and no elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBL) levels.
In a Phase II study (n=125), top-line results for once-daily ASC30 tablets showed statistically significant and clinically meaningful placebo-adjusted mean weight loss that was dose-dependent, with no plateau observed. At Week 13, placebo-adjusted weight loss for maintenance doses of 20 mg, 40 mg, and 60 mg was 5.4%, 7.0%, and 7.7%, respectively. Mean baseline body weight was 107.3 kg, and body mass index (BMI) was 38.6 kg/m². In terms of safety, the incidence of vomiting with ASC30 titrated weekly to the target dose was approximately half of that observed with OFG titrated weekly. The gastrointestinal (GI) tolerability of weekly-titrated ASC30 was comparable to that of published results for OFG titrated every four weeks in the Phase III ATTAIN-1 study. In this Phase II study of ASC30, all GI adverse events (AEs) were Grade 1 (mild) and Grade 2 (moderate), with no Grade 3 (severe) or higher GI AEs. There were no Grade 3 (severe) or higher drug-related AEs. No drug-related serious adverse events (SAEs) were reported. Discontinuation rates due to AEs in the 20 mg, 40 mg, and 60 mg groups were 7.3%, 7.5%, and 0.0%, respectively, compared to 0.0% in the placebo group. No liver safety signals were observed, and no elevations in ALT, AST, or TBL levels were noted. Additionally, no abnormalities were found in laboratory tests, vital signs, electrocardiograms (including QTc interval), or physical examinations.
Key Conclusions
ASC30 oral tablets demonstrated dose-dependent weight loss and a favorable GI tolerability profile compared to OFG, supporting its potential as a best-in-class oral GLP-1R agonist. Global Phase III clinical trials for treating obesity are expected to initiate by the end of the third quarter of 2026. The Phase III program will include two 72-week randomized, double-blind, placebo-controlled studies evaluating once-daily oral ASC30 at maintenance doses of 20 mg, 40 mg, and 60 mg, with a dose titration period of up to 20 weeks, in obese or overweight subjects with or without type 2 diabetes.
3. Oral GLP-1R/GIPR/GCGR Triple Agonist Peptide: ASC37
ASC37 is an oral GLP-1R/GIPR/GCGR triple agonist peptide developed using Ascletis’ proprietary oral peptide delivery enhancement technology (POTENT). By inhibiting enzymatic degradation and increasing gastrointestinal permeability, POTENT can improve the oral bioavailability of peptides from <1% to approximately 3%–5%. In non-human primates, the absolute oral bioavailability of semaglutide using Ascletis’ POTENT formulation was 3 times that of semaglutide using its commercial SNAC (N-8-(2-hydroxybenzamido)octanoate sodium) formulation; the absolute oral bioavailability of tirzepatide using Ascletis’ POTENT formulation was 9 times that of tirzepatide using the SNAC formulation.
Using the POTENT platform, in a head-to-head study in non-human primates, ASC37 oral tablets achieved a mean absolute oral bioavailability of 4.2%, approximately 30 times and 60 times that of tirzepatide and retatrutide using SNAC formulations, respectively. Additionally, in non-human primate studies, the mean observed half-life of ASC37 oral tablets was approximately 56 hours, supporting once-daily or potentially less frequent oral dosing.
Key Conclusions
ASC37 is an oral GLP-1R/GIPR/GCGR triple agonist peptide with favorable oral bioavailability and a long half-life, offering promising prospects for clinical development in obesity and other metabolic diseases.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of drugs that have the potential to be best-in-class and first-in-class for treating metabolic diseases. Leveraging its proprietary AI-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP) technology, and Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has independently developed multiple small molecule and peptide drug candidates, including its core program ASC30, an investigational small molecule GLP-1R agonist that can be administered either once daily orally or once monthly to once quarterly subcutaneously as a weight loss therapy and weight maintenance therapy for long-term weight management; ASC36, an amylin receptor agonist peptide; ASC35, a once-monthly subcutaneous GLP-1R/GIPR dual agonist peptide; ASC37, a GLP-1R/GIPR/GCGR triple agonist peptide; ASC39, a potent oral small molecule amylin receptor agonist similar to eloralintide with selectivity for amylin; and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin receptor agonist) for long-term weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit: www.ascletis.com.
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