SAN DIEGO, Calif. — 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, announced that the first patient has been dosed in Australia in its Phase 3 HERO pivotal clinical trial assessing ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi syndrome (PWS). Additionally, regulatory clearance for enrollment by clinical trial sites in Canada and the United Kingdom has also been received. Based on strong enrollment in the US and continued progress in advancing the clinical trial internationally, the clinical trial continues to track towards a topline data readout in Q3 2026.
“We have seen very strong interest in the HERO trial within the patient community, which has been driving enrollment in the United States and in our newly opened Australia sites,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “In addition, all patients who have completed the 12-week clinical trial to date have enrolled in the Open Label Extension trial, which is an encouraging indicator of patient interest and engagement.”
US trial sites are actively enrolling, and sites in Australia started enrolling in November. Enrollment is expected to initiate shortly in Canada and the UK, where regulatory clearance has been received. At this time, Aardvark anticipates that it will not need to activate previously planned sites in the EU to fully enroll the HERO trial and meet its anticipated timeline for topline data readout in Q3 2026.
“It’s important to note that significant unmet needs continue to persist in the PWS community, and many families are eager for a therapy that could ameliorate the relentless hunger that is a hallmark of PWS,” added Manasi Jaiman, M.D., Chief Medical Officer of Aardvark.
About the HERO Trial
The Hunger Elimination or Reduction Objective (HERO) trial (NCT06828861) is a Phase 3 randomized, double-blind, placebo-controlled trial assessing ARD-101 for the treatment of hyperphagia in patients with Prader-Willi syndrome (PWS). Aardvark plans to enroll 90 patients in this clinical trial across the US, Australia, Canada, the United Kingdom, and South Korea. The primary endpoint is change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12. Secondary outcome measures include change in Caregiver Global Impression of Severity (CaGI-S) for hyperphagia in PWS patients and change in Clinical Global Impression of Severity (CGI-S) score for hyperphagia in PWS patients. Topline data is expected in the third quarter of 2026.
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 PWS.
ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with 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 and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, through two separate Phase 2 trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com.
Contact
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
[email protected]