Aardvark Expands Phase 3 HERO Trial to Ages 7+, Seeks FDA Approval
IRB approval and FDA submission for an amended protocol lower the minimum age in Aardvark Therapeutics’ Phase 3 HERO trial of ARD-101 from 10 to 7 years, broadening U.S. eligibility. Enrollment remains on track with topline data expected in third quarter 2026.
1. Protocol Amendment Approval
Aardvark Therapeutics received U.S. Institutional Review Board approval and submitted an amended protocol to the FDA for its Phase 3 HERO trial evaluating ARD-101 in Prader-Willi Syndrome. The amendment lowers the minimum participant age from 10 to 7 years, expanding trial eligibility across U.S. sites.
2. Expanded Enrollment and Timeline
Following the protocol change, enrollment continues across planned sites in the U.S., Australia, Canada, the U.K. and South Korea targeting 90 participants. The company remains on schedule to report topline HERO trial results in the third quarter of 2026.
3. ARD-101 Mechanism and Designation
ARD-101 is a gut-restricted small-molecule agonist of bitter taste receptors that stimulates release of GLP-1 and CCK hormones to suppress hyperphagia in PWS patients. The therapy holds Orphan Drug and Rare Pediatric Disease designations, supporting its potential differentiated role in treating insatiable hunger.