The FDA has verbally notified Regulus Therapeutics that its investigational new drug RG-101 for the treatment of chronic hepatitis C virus infection has been placed on clinical hold after a second patient reported a serious adverse event, according to a news release.
The FDA initiated the clinical hold after Regulus reported the serious adverse event of jaundice, which occurred in a patient with end-stage renal disease on dialysis 117 days after receiving a single dose of RG-101 (Regulus Therapeutics), an anti-miR targeting miR-122, according to the release. The patient was enrolled in an ongoing phase 1 clinical trial at the time the adverse event occurred.
Regulus expects to receive 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, according to the release. In addition, Regulus noted they do not expect three ongoing studies of RG-101 to be affected by the clinical hold since all patients have been enrolled and completed RG-101 dosing.
Regulus recently announced it expanded its clinical trial agreement with GlaxoSmithKline and will conduct a phase 2 study evaluating RG-101 with GSK28728175 (GlaxoSmithKline) for chronic HCV. Researchers will assess RG-101, an anti-miR targeting miR-122, in combination with GSK28728175 as a single visit cure in patients who have chronic HCV.
In a previous trial, RG-101 alone successfully reduced mean viral loads in a small cohort of treatment-naive patients and patients who relapsed with other treatment.