The FDA has accepted Antag Therapeutics’ Investigational New Drug (IND) application for its lead molecule, AT-7687, for the treatment of obesity. AT-7687 is a peptide glucose-dependent insulinotropic polypeptide (GIP) receptor antagonist designed for once-weekly subcutaneous administration.
FDA approval 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.
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 safety, tolerability, and pharmacokinetics of AT-7687 alone and in combination with semaglutide in healthy lean and healthy obese subjects.
"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."
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