FDA places full clinical hold on Aardvark’s drug for extreme hunger in Prader-Willi syndrome

May 14 (Reuters) – Aardvark Therapeutics on Thursday said the U.S. Food and Drug Administration placed a full clinical hold on its drug to treat extreme hunger linked to the rare disorder Prader-Willi syndrome, halting all late-stage trials.

Shares of the company fell about 14% in after-hours trading.

Aardvark had paused enrollment and dosing in February after it found heart-related side effects in healthy volunteers given higher-than-planned doses of the drug, ARD-101.

• The FDA’s clinical hold applies to all studies on ARD-101, including a late-stage trial and extension study in Prader-Willi syndrome.

• The hold follows a previously announced voluntary pause, the company said, adding that it is in active discussions with the regulator to resolve the issue.

• The drug developer said that 68 patients were dosed in the main study and 19 in the extension as of late February.

• It added that it would review study data to assess safety and efficacy and determine next steps.

• Aardvark’s ARD-101, being developed as an oral medication, works by triggering gut hormones through activation of taste receptors.

• The company said it had $91.2 million in cash and investments as of March-end, which it expects will fund operations into mid-2027.

(Reporting by Sahil Pandey in Bengaluru; Editing by Diti Pujara)