Aardvark to Unblind ARD-101 Data After FDA’s Full Clinical Hold
FDA placed a full clinical hold on Aardvark Therapeutics’ ARD-101 IND, suspending its Phase 3 HERO trial for Prader-Willi hyperphagia and the open-label extension study. The company will unblind data from 68 HERO and 19 extension patients to evaluate efficacy and safety, and holds $91.2 million to fund operations into mid-2027.
1. FDA Imposes Full Clinical Hold
Aardvark’s IND application for ARD-101 has been placed on full clinical hold by the FDA, halting enrollment and dosing in both the Phase 3 HERO trial targeting hyperphagia in Prader-Willi Syndrome and its open-label extension study.
2. Unblinding of Trial Data
The company plans to unblind efficacy and safety data from 68 patients in the randomized HERO trial and 19 participants in the open-label extension to inform discussions on a path forward with regulators.
3. Patient Enrollment Status
As of February 27, 2026, Aardvark had dosed 68 participants in the controlled HERO trial (AVK-101-301) and 19 patients in the OLE trial (AVK-101-302), representing significant progress before the clinical hold.
4. Financial Runway into Mid-2027
With $91.2 million in cash, cash equivalents, and short-term investments as of March 31, 2026, the company expects to fund operations through mid-2027 while engaging with the FDA.