BioCentury
ARTICLE | Clinical News

RG-101: FDA hold

July 11, 2016 7:00 AM UTC

FDA placed a full clinical hold on RG-101 after Regulus reported a second severe adverse event of jaundice in an RG-101-treated patient. An HCV-infected patient with end-stage renal disease (ESRD) on dialysis developed jaundice 117 days after receiving a single dose of subcutaneous RG-101 in an ongoing, open-label, U.S. Phase I trial. Regulus said the study’s investigator believe the event was “unlikely” to be related to treatment. The trial evaluated single doses of 2 mg/kg RG-101 in 8 healthy volunteers, 8 patients with severe renal impairment or ESRD and 8 HCV-infected patients with severe renal impairment or ESRD.

The first case of jaundice occurred in a treatment-naive patient with chronic HCV infection 21 days after completing treatment in a Phase II trial evaluating 2 mg/kg RG-101 followed by an approved once-daily direct-acting-antiviral (DAA) for 28 days and a second dose of RG-101 on day 29. Regulus previously reported data from the Phase II trial (see BioCentury, April 25). ...