Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687

COPENHAGEN, Denmark, Oct. 9, 2024 /PRNewswire/ -- Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity, today announced that the U.S. 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."

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 safety, tolerability, and pharmacokinetics of AT-7687 alone and in combination with semaglutide in healthy lean and healthy obese subjects.

Notes to Editors

About AT-7687

The development of AT-7687 builds on the groundbreaking discovery of a novel human metabolite by world-renowned Professor Jens Holst, the discoverer of GLP-1, and his colleagues. In addition to promising preclinical data, the therapeutic potential of AT-7687 is further supported by robust human genetic validation, demonstrating that reducing GIP receptor activity is associated with leanness.

About Antag Therapeutics

Antag Therapeutics is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies for obesity and cardiometabolic diseases through GIP receptor antagonism. As a pioneer in exploring the potential of GIP receptor antagonists, the company is dedicated to advancing science and improving patient outcomes by delivering groundbreaking solutions that address unmet medical needs. For more information, please visit https://antagtherapeutics.com.