Aardvark Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause.
The clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AVK-101-301) evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS) and the Phase 3 open-label extension (OLE) trial (AVK-101-302).
The Company remains in active discussions with the FDA to support resolution of the clinical hold and determine a path forward for the ARD-101 program.
“We are continuing to work collaboratively with the agency to comprehensively evaluate the data and determine the best path forward for ARD-101,” said Tien Lee, MD, Founder and Chief Executive Officer of Aardvark. “Patient safety will always be the highest priority for us, and we are deeply committed to the PWS community. We remain committed to advancing ARD-101 as a potential therapy for this underserved patient population."
In parallel with its ongoing engagement with the FDA, Aardvark intends to unblind the clinical data accumulated to date across both the HERO trial and the OLE trial to assess the totality of available efficacy and safety data and to support an informed determination of next steps for the ARD-101 program.
