FDA lifts Aardvark's ARD-101 hold as further trial planning continues

Aardvark Therapeutics ($AARD) said the FDA lifted the clinical hold on ARD-101, its investigational treatment for excessive hunger associated with Prader-Willi syndrome. The hold followed a voluntary dosing pause after reversible electrocardiogram changes were observed in a separate healthy-volunteer study. The company subsequently supplied additional cardiac-safety evidence.

That work included a healthy-volunteer study at 200- and 400-milligram twice-daily doses and laboratory testing of a cardiac sodium channel. Aardvark plans to resume clinical development after further FDA engagement on the Phase 3 design. The earlier HERO trial and extension were stopped early and unblinded, so their available findings are exploratory rather than a definitive efficacy result. Removal of the hold permits development to progress but does not establish effectiveness or constitute marketing approval.

Sources:

• GlobeNewswire