Aardvark Therapeutics abandons phase 3 trials after workforce cuts and FDA hold

Aardvark Therapeutics announced it is walking away from its recently terminated phase 3 trials, stating there are no plans to resume them as originally designed.

The decision follows a reduction in staff, with the workforce shrinking from 40 employees and 35 consultants in April to 28 employees and 27 consultants by the end of July.

Earlier this year, reversible cardiac observations in healthy volunteers led to a pause in the phase 3 trial of its lead candidate ARD-101 for Prader-Willi syndrome, and the pause was later extended to ARD-201, a phase 2 combination study. In May, the FDA placed a full clinical hold on all ARD-101 studies, and the company subsequently terminated the trials in June citing operational and regulatory reasons.

Aardvark plans to unblind results from the PWS trial and its open-label extension while seeking a path forward for its stalled pipeline.