(RTTNews) - Aardvark Therapeutics (AARD) announced alignment with the FDA on a protocol amendment to the Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome. The protocol amendment changes the minimum age of eligibility to participate in the trial from 13 to 10 years old. The company targets topline data readout for this potentially pivotal trial in the third quarter of 2026.
"Expansion of the Phase 3 HERO trial to include children 10 years of age and older will allow us to reach a larger segment of the PWS patient population to potentially serve more patients in need," said Tien Lee, Founder and CEO of Aardvark.
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