The report also highlighted a voluntary pause in the Phase 3 HERO and OLE trials for ARD-101, aimed at treating hyperphagia in individuals with Prader-Willi Syndrome (PWS). This decision follows unexpected cardiac observations in a separate healthy volunteer trial. Aardvark is actively engaging with the FDA to determine the best path forward for its programs and expects to provide further guidance in Q2 2026.
In addition, the company has paused the ARD-201 obesity program, which includes the POWER and STRENGTH trials, pending next steps with ARD-101. Despite these setbacks, Aardvark remains optimistic about the potential of ARD-101, citing positive clinical data and an encouraging safety profile from previous trials. The company is committed to resuming its development program for PWS as soon as possible.
Aardvark's leadership emphasized the importance of patient safety and collaboration with the PWS community throughout this process. The company plans to continue its evaluation of ARD-101 as a potential therapy for pathological hunger and hyperphagia, including in PWS, and is looking forward to sharing more updates in the coming months.