Chinese biotechnology company Ascletis Pharma Inc (HKEX:1672) announced on Sunday that it has selected ASC37 oral tablets, its first oral GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate.
The company expects to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for ASC37 oral tablets for the treatment of obesity in the second quarter of 2026.
The product is the company's first incretin drug candidate developed with its proprietary Peptide Oral Transport ENhancement Technology (POTENT). It is a GLP-1R, GIPR, and GCGR triple peptide agonist that was discovered and optimised in-house using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD).
According to Ascletis, ASC37 in vitro activity was approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR and GCGR, respectively. Using Ascletis' POTENT technology, ASC37 oral tablets achieved average absolute oral bioavailability of 4.2%, which was approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide in the oral SNAC formulation, respectively, in head-to-head non-human primate (NHP) studies. After oral administration, ASC37 oral tablets' drug exposure, as measured by the area under curve (AUC), with the POTENT formulation was approximately 57-fold of retatrutide's drug exposure with the oral SNAC formulation, in head-to-head NHP studies. Average observed half-life of ASC37 oral tablets was approximately 56 hours in NHP studies, supporting once daily and less frequent oral dosing.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval