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Officials with Regulus Therapeutics Inc. have announced they received verbal notice from the
US Food and Drug Administration (FDA) that the Investigational New Drug (IND) for RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on clinical hold after a second report of jaundice.
The serious adverse event of jaundice occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going phase 1 US study 117 days after receiving a single dose of RG-101.
Officials with Regulus said in a prepared statement they anticipate a formal clinical hold letter from the FDA within 30 days and plans to work diligently with the agency to seek the release of the clinical hold.
Timelines for Regulus’ three on-going studies of RG-101 are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits.
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