RG-101 placed on clinical hold
On June 27, 2016, we issued a press release announcing we received verbal notice from the U.S. Food and Drug Administration (FDA) that our Investigational New Drug (IND) for RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on full clinical hold. We anticipate we will receive a formal clinical hold letter from the FDA within 30 days and plan to work diligently with the agency to seek the release of the clinical hold.
The FDA initiated the clinical hold after we reported a second serious adverse event (SAE) of jaundice. The SAE occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going Phase I US study 117 days after receiving a single dose of RG-101.
Timelines for our 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. We remain on track to deliver follow-up results from these studies at upcoming scientific meetings.
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