Ascletis Pharma Receives FDA Clearance for Phase I Study of ASC35 Obesity Drug

Ascletis Pharma announced in a press release that it has received Investigational New Drug clearance from the U.S. Food and Drug Administration (FDA) for a Phase I study of ASC35, a once-monthly subcutaneous GLP-1 and GIP dual peptide agonist for obesity treatment.

The randomized, double blind, placebo controlled trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 in 84 participants who are obese or overweight with weight related conditions. The study includes a single ascending dose phase and a multiple ascending dose phase comparing ASC35 with tirzepatide, an FDA approved weekly formulation.

ASC35 was discovered and developed using Ascletis' Artificial Intelligence Assisted Structure Based Drug Discovery technology and formulated with its Ultra Long Acting Platform. The Self Assembling Lipid Depot formulation is designed for once monthly administration, forming a gel like depot under the skin that gradually releases the active ingredient.

Preclinical studies in non human primates showed that ASC35 had an average half life about six times longer than tirzepatide and higher drug exposure levels. In comparative mouse studies, ASC35 demonstrated greater efficacy and potency for GLP-1 and GIP receptor activation than tirzepatide.