Antag Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687.

This milestone enables Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects.

The study will also explore AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals.

"We are thrilled to receive the FDA's acceptance of our IND application for AT-7687," said Alexander Sparre-Ulrich, Founder & CEO of Antag Therapeutics.

"This marks a major step forward in advancing our clinical development program and brings us closer to providing a potential new treatment for patients with obesity and cardiometabolic diseases. We are excited to begin our Phase I study and further demonstrate the therapeutic potential of AT-7687 and GIPR antagonism," he added.

AT-7687 is a peptide GIP receptor antagonist designed for once-weekly subcutaneous administration. Highly translational preclinical studies have shown that AT-7687 attenuates weight gain and enhances GLP-1-mediated weight loss while improving lipid profiles, particularly LDL, independent of weight change.

Importantly, these benefits are not associated with gastrointestinal side effects. The upcoming Phase I trial will assess the safety, tolerability, and pharmacokinetics of AT-7687 alone and in combination with semaglutide in healthy lean and healthy obese subjects.