Aardvark Therapeutics Announces First Patient Dosed in Australia in HERO Phase 3 Trial for Prader-Willi Syndrome

Core Insights - Aardvark Therapeutics is progressing with its Phase 3 HERO trial for ARD-101, targeting hyperphagia in Prader-Willi syndrome (PWS), with topline data expected in Q3 2026 [1][4][6] Group 1: Clinical Trial Progress - The first patient has been dosed in Australia, and regulatory clearance for enrollment has been received in Canada and the UK [1][2] - Strong enrollment is reported in the US, with all patients from the completed 12-week trial participating in the Open Label Extension trial, indicating high patient engagement [2][3] - Aardvark anticipates that it will not need to activate previously planned sites in the EU to meet enrollment goals for the HERO trial [2] Group 2: Trial Details - The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled study enrolling 90 patients across multiple countries [4] - The primary endpoint is the change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12, with secondary measures including caregiver and clinical global impressions of severity [4] Group 3: Product Information - ARD-101 is a gut-restricted small molecule agonist that stimulates the release of gut-peptide hormones to mediate hunger, showing potential to reduce hunger when used alone or with GLP-1 therapies [5][6] - The FDA has granted ARD-101 Orphan Drug Designation and Rare Pediatric Disease Designation for PWS [5] Group 4: Company Overview - Aardvark Therapeutics focuses on developing small-molecule therapeutics to suppress hunger for metabolic diseases, with ARD-101 as its lead compound in clinical development for hyperphagia associated with PWS [7][8]