Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug

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The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

Antag Therapeutics has announced that the FDA has accepted the investigational new drug (IND) application for its lead drug candidate, AT-7687. This will enable Antag Therapeutics to initiate a phase 1 clinical trial to evaluate the small molecule drug candidate in both healthy lean and healthy obese individuals. The study will also explore the combination of AT-7687 and semaglutide, the active compound of weight management drugs Ozempic and Wegovy.

“We are thrilled to receive the FDA’s acceptance of our IND application for AT-7687,” said Alexander Sparre-Ulrich, Founder and 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.”

Based in Copenhagen, Denmark, Antag Therapeutics is a biopharmaceutical company developing treatments for obesity and cardiovascular disease that target the glucose-dependent insulinotropic polypeptide (GIP) receptor. The company’s first-in-class therapeutic peptides are optimized analogues of a molecule that inhibits the GIP receptor that is naturally found in the human body.

The market for weight loss drugs has exploded since the approval of Novo Nordisk’s GLP-1 receptor agonist, semaglutide, in 2021, followed by Eli Lilly’s combined GLP-1 and GIP agonist tirzepatide in 2022. Multiple companies are currently developing drugs with similar mechanisms of action with the goal of tapping into this rapidly growing market.

Antag Therapeutics was founded in 2017 backed by a €2.7 million investment from Novo Seeds, the early-stage investment arm of Novo Holdings, which manages the assets of the Novo Nordisk Foundation. The company’s lead candidate, AT-7687, is a peptide GIP receptor antagonist, designed to be administered subcutaneously once a week. The development of this drug candidate is based on research by Professor Jens Juul Holst at the University of Copenhagen, co-founder of Antag Therapeutics and discoverer of GLP-1.

Preclinical studies have shown that AT-7687 could reduce weight gain and enhance the weight loss effects mediated by GLP-1, which is the target of obesity drugs such as semaglutide. The drug has also shown potential to improve cholesterol profiles without causing gastrointestinal side effects.