Aardvark Therapeutics dosed the first patient in Australia for the Phase 3 HERO pivotal clinical trial on ARD-101 for treating hyperphagia in Prader-Willi Syndrome patients.
Multiple active sites in the US and enrollment progress internationally indicate a Q3 2026 topline data readout.
Canada and the UK received clearance for enrollment, and all patients completing the trial to date joined the Open Label Extension trial.
Strong Patient Interest
HERO trial attracted high patient interest, driving enrollment in the US and Australia.
Global Enrollment Progress
Regulatory clearances in Canada and the UK support expanding the trial internationally.
Promising Patient Engagement
All patients completing the 12-week trial enrolled in the Open Label Extension, showing positive patient engagement.
Unmet PWS Need
Significant unmet needs in the PWS community highlight the demand for effective therapies to address relentless hunger.
- The HERO trial is a Phase 3 study evaluating ARD-101 for hyperphagia in Prader-Willi Syndrome patients.
- ARD-101, a gut-restricted agonist of taste receptors, shows promise in hunger suppression through gut-brain signaling.
- The FDA granted ARD-101 Orphan Drug and Rare Pediatric Disease Designations for its potential in PWS treatment.
Aardvark Therapeutics' progress in the HERO trial indicates a step closer to addressing the unmet needs in the PWS community. With strong patient interest and global enrollment, the company is on track for a significant milestone in Q3 2026.