Aardvark pauses late-stage trial testing rare disease treatment

Feb 27 (Reuters) – Aardvark Therapeutics is voluntarily pausing its late-stage trial testing its experimental treatment for a type of rare genetic disease after it found heart-related side effects in healthy volunteers, the company said on Friday.

The company said it decided to pause the late-stage study “out of an abundance of caution” after it found some heart-related side effects during safety monitoring in a healthy volunteer study in patients receiving higher‑than‑planned doses of the treatment.

Aardvark was testing ARD-101 as a potential treatment for hyperphagia, or feelings of intense and persistent hunger, in patients with a rare genetic disorder called Prader-Willi syndrome.

The company said it is conducting a comprehensive review of the data to inform next steps.

“We are committed to advancing the ARD-101 clinical program and we are evaluating optimal therapeutic dosing levels to support its progress,” CEO Tien Lee said in a statement.

ARD-101 is designed to release multiple gut-peptide hormones, including GLP-1 to mediate hunger. ARD-101 has been shown to reduce hunger when used in combination with currently available GLP-1 therapies, the company said.

Currently, only one FDA-approved treatment exists for hyperphagia, a once-daily oral pill called Vykat XR by Soleno Therapeutics .

Last year, Acadia Pharmaceuticals said it will discontinue development of its intranasal therapy to treat Prader-Willi syndrome after it failed to show a benefit in patients in a late-stage trial.

(Reporting by Sneha S K in Bengaluru; Editing by Maju Samuel)