The FDA has placed a full clinical hold on the investigational new drug application (IND) for ARD-101, an oral drug from Aardvark Therapeutics to treat hyperphagia in patients with Prader-Willi syndrome (PWS).
The clinical hold applies to all ongoing clinical trials, which include the phase 3 HERO trial and phase 3 open-label extension (OLE) trial. In response to the FDA’s decision, Aardvark announced that it will unblind data from these trials to enable the assessment of efficacy and safety data, with the aim of finding a means to continue the ARD-101 program.
Aardvark had already voluntarily paused the trials due to “reversible cardiac observations.” These occurred when, during routine safety monitoring of the trials, the company observed reversible cardiac issues in healthy volunteers who were taking above target therapeutic doses.