– Utilizing Ascletis’ peptide oral transport enhancement (POTENT) technology, ASC37 oral tablets achieved an average absolute oral bioavailability of 4.2%, or approximately 9–30–, And 60 times higher than semaglutide, tirzepatide and retatrutide in the oral formulation of SNAC, respectively, in comparative studies in non-human primates (NHP).
– Drug exposure from ASC37 oral tablets, as measured by the Areal Youbelow ccave (AUC), was approximately 57 times higher than retatrutide exposure in NHP comparative studies.
– The average observed half-life of ASC37 oral tablets was approximately 56 hours in NHP studies, supporting once daily and less frequent oral administration.
– The in vitro activity of ASC37 was approximately 5-, 4-, and 4-fold more potent than that of retatrutide for GLP-1R, GIPR, and GCGR, respectively.
– Submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets 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 December 1, 2025.
HONG KONG, November 30, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces that it has selected ASC37 oral tablets, its first GLP-1R/GIPR/GCGR oral tablets[1] triple peptide agonist, as a candidate for clinical development. Ascletis plans to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets for the treatment of obesity in the second quarter of 2026.
ASC37 Oral Tablets are the Company’s first incretin drug candidate developed with its proprietary Peptide Oral Transport Enhancement (POTENT) technology.
ASC37, a triple peptide agonist of GLP-1R, GIPR and GCGR, was discovered and optimized in-house using Ascletis’ artificial intelligence-assisted structure-based drug discovery (AISBDD). ASC37 in vitro the activity was approximately 5-, 4-, and 4-fold more potent than that of retatrutide for GLP-1R, GIPR, and GCGR, respectively.
Using Ascletis’ POTENT technology, ASC37 oral tablets achieved average absolute oral bioavailability[2] by 4.2%, which was approximately 9, 30, and 60 times higher than semaglutide, tirzepatide, and retatrutide in oral SNAC [3] formulation, respectively, in comparative studies on non-human primates (NHP). Additionally, after oral administration, drug exposure from ASC37 oral tablets, as measured by area under the curve (AUC), with the POTENT formulation was approximately 57 times greater than drug exposure from retatrutide with the SNAC oral formulation, in comparative NHP studies.
The average observed half-life of ASC37 oral tablets was approximately 56 hours in NHP studies, supporting once daily and less frequent oral administration.
“The selection of ASC37, a promising oral GLP-1R/GIPR/GCGR triple peptide agonist, for clinical development once again demonstrates our strong R&D capabilities and commitment to addressing unmet needs for the treatment of obesity,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. potentially effectively address the diverse treatment needs of patients suffering from obesity and other metabolic diseases.
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[1] GLP-1R: glucagon-like peptide 1 receptor, GIPR: gastric inhibitory polypeptide receptor, GCGR: glucagon receptor [2] absolute oral bioavailability: percentage of an orally administered drug that reaches the systemic circulation (bloodstream), compared to an intravenous (IV) dose of the same drug [3] SNAC: Salcaprozate sodium |
Conference call
Ascletis will host a conference call in Mandarin at 10:00 a.m. China Standard Time on December 1, 2025. A live webcast of the call will be available via Tencent Meeting/VooV Meeting, with meeting ID: 495-266-842, or access links of:
Mainland China: https://meeting.tencent.com/dm/10ve6whW8Rbl; Or
International: https://voovmeeting.com/dm/10ve6whW8Rbl.
About Ascletis Pharma inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential first-in-class and first-in-class therapeutic products to treat metabolic diseases. Using its proprietary artificial intelligence-driven drug discovery (AISBDD) and ultra-long-acting platform (ULAP) technologies, as well as its Oral Peptide Transport Enhancement (POTENT) technology, Ascletis has developed several drug candidates in-house, including small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered orally once daily and once monthly to a times per quarter subcutaneously as treatment. therapy and maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist administered subcutaneously once monthly, ASC35, a GLP-1R/GIPR dual peptide agonist administered subcutaneously once monthly, and ASC37, an oral GLP-1R/GIPR/GCGR triple peptide 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:
Pierre Vozzo
ICR Health
443-231-0505 (United States)
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.
