Aardvark Therapeutics will voluntarily pause its phase 3 HERO trial of ARD-101 to treat hyperphagia (constant hunger) in patients with Prader-Willi Syndrome (PWS) due to "reversible cardiac observations."
During routine safety monitoring of the HERO and open label extension trials, the company observed reversible cardiac issues in healthy volunteers who were taking above target therapeutic doses. Before continuing with the trials, Aardvark will conduct a comprehensive review of the data. The company no longer expects to release topline data in Q3 2026, but it does intend to provide an update in Q2.
ARD-101 is a gut-restricted small molecule agonist of bitter taste receptors expressed in the lumen of the intestine. The receptor pan-agonist causes the digestive tract to release gut-peptide hormones by stimulating enteroendocrine cells. This reduces the sensation of hunger, both when taken alone and in combination with a GLP-1.
The San Diego-based biotech raised $94.2 million in an initial public offering in February 2025 to fund the development of its small molecule therapeutics that activate innate homeostatic pathways for the treatment of metabolic diseases.