SAN DIEGO, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS).
The decision by Aardvark to voluntarily pause the HERO (NCT06828861) and open-label extension (NCT07197034) trials was based on reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study. Aardvark is conducting a comprehensive review of the data to inform next steps. Out of an abundance of caution, the company has voluntarily paused ongoing enrollment and dosing in the HERO trial during this evaluation.
“The safety of every patient in our clinical studies is our highest priority, so we will thoroughly evaluate the signals seen at higher than therapeutic doses of ARD-101 in a healthy volunteer study,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We are committed to advancing the ARD-101 clinical program and we are evaluating optimal therapeutic dosing levels to support its progress. We will continue to collaborate closely with the FDA and scientific and clinical experts, and we greatly appreciate our partnership with the PWS community as we determine next steps for this program.”
Based on the ongoing activities in the ARD-101 program, Aardvark no longer anticipates announcing topline data from the HERO trial in the third quarter of 2026 and expects to provide further guidance in the second quarter of this year.
About ARD-101
ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed on the luminal side of the intestine. As a potent bitter taste receptor pan-agonist, ARD-101 stimulates enteroendocrine cells of the digestive tract to release multiple gut-peptide hormones, including GLP-1 and the satiety hormone cholecystokinin (CCK), which activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome (PWS).
About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. For more information, visit www.aardvarktherapeutics.com.
