Aardvark Therapeutics Doses First Patient In Australia In Phase 3 HERO Trial Of ARD-101 For Hyperphagia In Prader-Willi Syndrome

Aardvark Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapies that activate innate homeostatic pathways to treat metabolic diseases, announced that the first patient has been dosed in Australia in its Phase 3 HERO pivotal trial evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi syndrome (PWS). 

The company also confirmed that regulatory approvals have been obtained for clinical trial enrollment in Canada and the United Kingdom. With strong enrollment in the United States and continued progress internationally, the trial remains on track for a topline data readout in the third quarter of 2026.

Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark, highlighted that the HERO trial has received strong interest from the patient community, which has supported enrollment both in the United States and at newly opened sites in Australia. He noted that all patients who have completed the initial 12-week trial have chosen to enroll in the Open Label Extension trial, reflecting high patient engagement and interest in the therapy.

U.S. trial sites continue active enrollment, and Australian sites began enrolling patients in November. Enrollment in Canada and the U.K. is expected to start soon following regulatory clearance. Based on current enrollment trends, Aardvark anticipates that it will not need to open previously planned European sites to achieve full enrollment and maintain the expected timeline for topline results in Q3 2026. 

Manasi Jaiman, M.D., Chief Medical Officer of Aardvark, emphasized the ongoing unmet needs in the PWS community, noting that families remain eager for a therapy that could help manage the persistent hunger that defines the condition. The HERO trial represents an important step toward addressing this significant clinical need.