Aardvark Therapeutics has received Institutional Review Board (IRB) approval in the US for an amended protocol to its Phase III HERO clinical trial of ARD-101 underway for hyperphagia in Prader-Willi Syndrome (PWS).
The amended trial protocol has been submitted to the US Food and Drug Administration (FDA), lowering the minimum enrolment age from ten to seven years.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The placebo-controlled, double-blind, randomised trial will evaluate ARD-101 in patients with PWS-related hyperphagia.
Aardvark intends to enrol 90 patients across Australia, Canada, South Korea, the UK, and the US. The primary endpoint is the hyperphagia questionnaire for clinical trials (HQ-CT) score change to week 12 from baseline.
Secondary outcomes being measured include change in caregiver global impression of severity (CAGI-S) and clinical global impression of severity (CGI-S) scores, both evaluating hyperphagia severity in PWS patients.
Participants completing the 12-week trial may enter an open-label extension study.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAardvark said that the protocol amendment aims to reduce participation barriers and improve access for individuals affected by PWS, a rare genetic condition marked by chronic hyperphagia.
By permitting enrolment of younger children who qualify, the HERO trial seeks to better evaluate ARD-101’s impact within the broader PWS population.
Aardvark Therapeutics founder and CEO Tien Lee said: “We are very pleased to report this important protocol expansion, which allows us to broaden the patient population for our Phase III HERO trial to include children as young as seven years of age in the US.
“Hyperphagia may begin early in life for some individuals with PWS, and it presents a persistent burden for patients and caregivers. Expanding eligibility reflects our commitment to addressing the urgent need in the PWS community for a differentiated therapy, and we aim to ensure broad and equitable access.
“Enrolment in HERO is progressing steadily and remains on track to report topline data in the third quarter of 2026. We believe these data will further inform our understanding of ARD-101’s potential role as a differentiated therapeutic approach for the treatment of hyperphagia associated with PWS.”
