The company’s strategy centers on improving patient adherence by moving away from the frequent injections currently required by standard treatments. CEO Jinzi Jason Wu noted that while existing options like eloralintide and tirzepatide require separate weekly injections to achieve significant weight loss, the new ASC36_35 fixed-dose combination offers a triple-target approach—amylin receptor, GLP-1R, and GIPR—in a single monthly subcutaneous dose.
Ascletis Targets Obesity Market with New Once-Monthly FDA Filings
Ascletis Pharma has filed two Investigational New Drug applications with the U.S. FDA, aiming to disrupt the obesity treatment landscape with long-acting, injectable therapies. The submissions focus on ASC36, a peptide amylin receptor agonist, and a co-formulation combining ASC36 with the GLP-1R/GIPR agonist ASC35.
Preclinical data suggest high efficacy for these candidates. In head-to-head studies using diet-induced obese rats, the ASC36_35 co-formulation reportedly showed a 51% greater relative body weight reduction than the combined administration of current market standards. Additionally, internal testing of ASC36 monotherapy showed significant weight loss advantages over petrelintide and eloralintide. The drugs utilize Ascletis’ proprietary Self-Assembling Lipid Depot technology, which extends the half-life of the compounds, potentially allowing for administration frequencies ranging from once-monthly to once-quarterly in human patients.
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