Antag Therapeutics Gets FDA Clearance for Lead Drug AT-7687 IND Application

COPENHAGEN, Denmark, Oct. 9, 2024 /PRNewswire/ -- Leading biopharmaceutical company Antag Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for its primary molecule, AT-7687. This approval allows Antag Therapeutics to commence its Phase I clinical trials aimed at evaluating the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese participants. Furthermore, the study will examine the effects of AT-7687 as a standalone treatment and in combination with semaglutide, a GLP-1 receptor agonist, specifically in healthy obese individuals.

Alexander Sparre-Ulrich, Founder & CEO of Antag Therapeutics, expressed the company's excitement about the FDA's acceptance of their IND application. He emphasized the significance of this development in progressing their clinical programs and the potential impact on treatments for obesity and cardiometabolic diseases. Sparre-Ulrich highlighted the company's eagerness to begin the Phase I study to showcase the therapeutic benefits of AT-7687 and GIP receptor antagonism.

AT-7687 is a peptide GIP receptor antagonist designed for once-weekly subcutaneous injection. Preclinical studies have demonstrated that AT-7687 can reduce weight gain and enhance GLP-1-mediated weight loss, while also improving lipid profiles, particularly LDL levels, independently of weight change. Notably, these positive effects are achieved without causing gastrointestinal side effects. The forthcoming Phase I trial will focus on the safety, tolerability, and pharmacokinetics of AT-7687 alone and in combination with semaglutide in both healthy lean and healthy obese participants.

AT-7687's development builds on the groundbreaking discovery of a new human metabolite by Professor Jens Holst, the scientist who discovered GLP-1, and his team. Along with promising preclinical results, the therapeutic potential of AT-7687 is further backed by strong human genetic validation, showing that reducing GIP receptor activity correlates with leanness.

Antag Therapeutics, a clinical-stage biopharmaceutical firm, is committed to developing innovative treatments for obesity and cardiometabolic diseases by targeting GIP receptor antagonism. The company is dedicated to advancing scientific knowledge and improving patient outcomes through pioneering solutions that address unmet medical needs.