Antag Therapeutics receives FDA approval for obesity drug trials

Antag Therapeutics has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) accepting its investigational new drug (IND) application for AT-7687, the company's lead drug candidate. This approval paves the way for Antag Therapeutics to commence a phase 1 clinical trial, which will investigate the effects of this small molecule drug candidate in both healthy lean and healthy obese individuals. Additionally, the study will assess the combined impact of AT-7687 with semaglutide, the active ingredient in popular weight management medications such as Ozempic and Wegovy.

Alexander Sparre-Ulrich, the Founder and CEO of Antag Therapeutics, expressed his enthusiasm about the FDA’s decision, stating that it represents a significant advancement in their clinical development program. He emphasized that this step brings them closer to offering a new potential treatment for individuals suffering from obesity and cardiometabolic diseases. Sparre-Ulrich highlighted the importance of the upcoming phase 1 study in demonstrating the therapeutic potential of AT-7687 and GIPR antagonism.

Antag Therapeutics, headquartered in Copenhagen, Denmark, is a biopharmaceutical firm dedicated to creating treatments for obesity and cardiovascular conditions by targeting the glucose-dependent insulinotropic polypeptide (GIP) receptor. The company specializes in developing first-in-class therapeutic peptides, which are optimized analogues of a naturally occurring molecule that inhibits the GIP receptor.

The landscape for weight loss drugs has seen substantial growth since Novo Nordisk’s GLP-1 receptor agonist, semaglutide, received approval in 2021. This was followed by the introduction of Eli Lilly’s combined GLP-1 and GIP agonist, tirzepatide, in 2022. Numerous pharmaceutical companies are now exploring drugs with similar mechanisms of action to capitalize on this burgeoning market.

Antag Therapeutics was established in 2017 with financial backing from Novo Seeds, the early-stage investment division of Novo Holdings. Novo Holdings manages the assets of the Novo Nordisk Foundation. The company's flagship candidate, AT-7687, is a peptide GIP receptor antagonist intended for subcutaneous administration once per week. The development of AT-7687 is grounded in research conducted by Professor Jens Juul Holst at the University of Copenhagen. Professor Holst, a co-founder of Antag Therapeutics, is renowned for his discovery of GLP-1.

Preclinical studies have demonstrated that AT-7687 can potentially reduce weight gain and enhance the weight loss effects induced by GLP-1, which is the active target of obesity medications like semaglutide. Furthermore, AT-7687 has shown promise in improving cholesterol profiles without inducing gastrointestinal side effects.

The FDA’s acceptance of the IND application for AT-7687 signifies a crucial progression for Antag Therapeutics as it moves towards initiating clinical trials and ultimately providing new therapeutic solutions for patients struggling with obesity and related cardiometabolic disorders. The phase 1 study will be essential in validating the efficacy and safety of AT-7687 and its combined use with semaglutide, potentially offering a novel approach to weight management and metabolic health.