Ascletis drug ASC37 shows superior weight loss in animal study

Ascletis Pharma Inc. has reported preclinical findings for its novel weight management candidate, ASC37. The company stated that its triple peptide agonist, which targets GLP-1R, GIPR, and GCGR receptors, achieved 88% greater relative body weight reduction in a diet-induced obese mouse model compared to tirzepatide when administered at the same dose for eleven days.

The weight loss observed with ASC37 was dose-dependent, reaching up to 41.5% at higher dosages. Ascletis plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for both the once-monthly subcutaneous (SQ) and oral formulations in the third quarter of 2026. Biologics License Application (BLA) submissions will follow completion of Phase III trials.

The manufacturer indicated that the ASC37 SALD (Self Assembly Lipid Depot) formulation exhibited an average half-life of approximately 17 days in non-human primates, supporting a monthly dosing frequency. This compares to a half-life of 2.5 days for retatrutide, another triple peptide agonist.

Ascletis CEO Jinzi Jason Wu expressed confidence in ASC37's potential as a first-in-class, once-monthly subcutaneous triple peptide agonist for severe obesity. The BLA regulatory pathway for biologics offers longer statutory exclusivity periods and protection from government price negotiations compared to small molecule drugs.

ASC37 is composed of 41 alpha amino acids, classifying it as a biologic. The company is also developing ASC35, a GLP-1R/GIPR dual peptide agonist, which will also pursue the BLA route. Ascletis is a biotechnology company focused on developing therapeutics for metabolic diseases.