Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome

Core Insights - Aardvark Therapeutics has aligned with the FDA on a protocol amendment for its Phase 3 HERO trial, lowering the minimum age for participation from 13 to 10 years old, which aims to include a larger segment of the Prader-Willi Syndrome (PWS) patient population [1][2] Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics to treat metabolic diseases, specifically targeting hunger suppression in conditions like PWS [5] - The lead compound, ARD-101, is a gut-restricted small molecule that acts as a pan-agonist for bitter taste receptors, stimulating the release of gut-peptide hormones to mediate hunger [3][5] Clinical Development - ARD-101 is currently being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS, with topline data expected in the third quarter of 2026 [2][4] - The decision to expand the trial's eligibility is supported by historical data indicating that younger patients may benefit more from early intervention [2]