Aardvark Therapeutics Reports Exploratory Data from the Terminated HERO and Open-Label Extension Trials

Aardvark Therapeutics reported exploratory efficacy data from its early-terminated Phase 3 HERO trial for ARD-101, a hunger-suppressing therapy for Prader-Willi syndrome. The drug showed modest reductions in hyperphagia scores and was generally well-tolerated, though one cardiac serious adverse event occurred at the highest dose in combination with another drug. The FDA lifted the clinical hold, allowing the company to resume development at lower doses and plan a new Phase 3 trial.