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Aardvark Therapeutics Announces FDA Has Lifted the Clinical Hold on ARD-101 for the Treatment of Prader-Willi Syndrome and Will Host Webcast to Review the Available Exploratory Phase 3 HERO/OLE Data

AARD
  • The FDA has lifted the clinical hold on Aardvark Therapeutics' Investigational New Drug application for ARD-101 to treat hyperphagia in Prader-Willi Syndrome.
  • Aardvark plans to resume clinical development of ARD-101 following anticipated alignment with the FDA on the Phase 3 trial design.
  • Dosing for the Phase 3 HERO trial and its open-label extension (OLE) was voluntarily paused on February 27, 2026, due to reversible ECG changes observed in healthy volunteers.
  • The FDA placed a clinical hold on the HERO and OLE trials in May 2026, prompting the company to conduct additional ECG studies in healthy volunteers.
  • No cardiac events were observed in the recently completed ECG study at ARD-101 doses of 200 mg and 400 mg twice daily.
  • Aardvark unblinded data from the terminated HERO and OLE trials to assess the totality of available efficacy and safety data.
  • The company will host a webcast on Friday, October 23, 2026, at 8:00 a.m. EST to review the dataset from the terminated trials.
  • ARD-101 is an oral, small-molecule therapeutic designed to stimulate gut-peptide hormone release via bitter taste receptor activation.