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FDA Places Full Clinical Hold on Aardvark’s ARD-101 Prader–Willi Trials

Heart concerns at higher doses now force a data unblinding to decide the program’s future.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Overview

  • Aardvark said the FDA imposed the hold Thursday, halting the Phase 3 HERO study and its open-label extension for ARD-101.
  • The company plans to unblind data from both trials to review safety and efficacy as it works with the regulator on next steps.
  • Aardvark had paused dosing in March after routine monitoring found reversible heart-related effects at higher-than-planned doses in healthy volunteers.
  • Shares fell about 14% in after-hours trading after the hold, and a shareholder law firm is examining the company’s past statements on safety and FDA communications.
  • As of February 27, 68 patients in the HERO trial and 19 in the extension had been dosed, giving the upcoming review a meaningful evidence base for a drug meant to ease constant hunger in Prader–Willi syndrome.