Aardvark Therapeutics Expands Phase 3 Trial Eligibility for Lead PWS Drug ARD-101 to Younger Children
Summary
Aardvark Therapeutics announced IRB approval to expand eligibility for its Phase 3 HERO trial of ARD-101 for Prader-Willi Syndrome, lowering the minimum age from 10 to 7 years old, and confirmed topline data is expected in Q3 2026.
Key Events
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Phase 3 Trial Eligibility Expanded
IRB approval granted to amend the protocol for the Phase 3 HERO trial of ARD-101, lowering the minimum age of eligibility for participation from 10 to 7 years old in the U.S.
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Addresses Rare Pediatric Disease
The protocol amendment aims to reduce barriers and expand access for individuals affected by Prader-Willi Syndrome (PWS), a rare genetic disorder, by including younger children.
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Topline Data On Track
Enrollment in the HERO trial is progressing steadily, with topline data still expected in the third quarter of 2026.
Analysis
Aardvark Therapeutics received Institutional Review Board (IRB) approval to amend the protocol for its pivotal Phase 3 HERO clinical trial of ARD-101, lowering the minimum age of eligibility from ten to seven years old for patients with Prader-Willi Syndrome (PWS). This expansion is significant as it broadens the potential patient population for the trial, allowing for earlier intervention in a rare pediatric disease where hyperphagia can begin early in life. The company also reiterated that enrollment for the HERO trial is progressing steadily and remains on track to report topline data in the third quarter of 2026, providing a positive update on its lead candidate's development timeline.
At the time of this filing, AARD was trading at $13.06 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $293.5M. The 52-week trading range was $4.88 to $19.58. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.