Ascletis Pharma Inc.'s ASC37, a once-monthly GLP-1R/GIPR/GCGR triple peptide agonist, demonstrated 88% greater relative body weight reduction compared with tirzepatide in diet-induced obese mice. The company plans to submit Investigational New Drug applications for both subcutaneous and oral formulations in the third quarter of 2026.
Ascletis Pharma Inc.'s ASC37, a once-monthly GLP-1R/GIPR/GCGR triple peptide agonist, demonstrated 88% greater relative body weight reduction compared with tirzepatide in diet-induced obese mice. The company plans to submit Investigational New Drug applications for both subcutaneous and oral formulations in the third quarter of 2026.
Ascletis Pharma Inc.'s ASC37, a once-monthly GLP-1R/GIPR/GCGR triple agonist, showed 88% greater weight loss than tirzepatide in obese mice.
"ASC37 has the potential to be a first-in-class once-monthly SQ triple peptide agonist for people living with severe obesity," Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, said.
Following 11-day administration at 1 nmol/kg, ASC37 achieved 14.1% total body weight reduction compared with 7.5% for tirzepatide (p=0.0279). At higher doses of 10 nmol/kg and 30 nmol/kg, ASC37 produced 30.1% and 41.5% weight loss, respectively, in a dose-dependent fashion. In non-human primate studies, ASC37's Self Assembly Lipid Depot formulation had an average half-life of approximately 17 days, about seven times longer than retatrutide's 2.5 days, supporting once-monthly or less frequent dosing.
The company plans to submit Investigational New Drug applications for both the once-monthly subcutaneous and oral formulations in the third quarter of 2026, with Biologics License Applications to follow after Phase III completion. ASC37's 41-amino-acid structure qualifies it as a biologic, offering 13 years of statutory exclusivity after FDA approval under the Inflation Reduction Act, compared with nine years for small molecules. The biologic designation also prevents compounding pharmacies from offering lower-price versions.
ASC35, a next-generation GLP-1R/GIPR dual peptide agonist with the same 41-amino-acid structure, will also follow the BLA pathway. Ascletis shares closed 2.1% lower at 9.00 Hong Kong dollars on Monday.
The preclinical data positions Ascletis to compete in the obesity market dominated by Novo Nordisk's Wegovy and Eli Lilly's Zepbound, which generated a combined $25 billion in sales last year. Investors will watch for IND clearance in the third quarter and the start of human trials, which will determine whether the mouse-model efficacy translates to patients.
This article is for informational purposes only and does not constitute investment advice.
