Aardvark Therapeutics Publishes HERO and OLE Trial Data Presentation
Bitget2026/10/23 14:41- Aardvark Therapeutics published its HERO and OLE data update on ARD-101 for Prader-Willi syndrome.
- The FDA lifted the clinical hold on the program; HERO enrolled 67 participants before dosing stopped February 27, 2026.
- HERO showed modest hyperphagia score reductions versus placebo; early termination left results exploratory.
- Former placebo participants showed roughly six-point additional improvement on ARD-101 in the extension; symptoms rebounded following treatment withdrawal.
- One Grade 4 cardiac event occurred at 800 mg twice daily in a participant taking pitolisant; HERO recorded no additional cardiac events.
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