Tuesday, July 12, 2016

FDA Puts Clinical Hold on Studies of Investigational MicroRNA Drug

The Food and Drug Administration recently placed a clinical hold on human trials involving a new investigational hepatitis C drug that targets microRNA following a report of jaundice by someone enrolled in a study, the drug developer Regulus Therapeutics announced.

Regulus said in a statement that the company learned of a clinical hold on RG-101, its investigational new drug, via a verbal notice from the FDA. The hold was initiated after Regulus, a San Diego-based company, reported a second serious adverse event (SAE) of jaundice, according to the statement.

“Regulus anticipates it will 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,” company officials said in the statement.

A patient with hepatitis C experienced jaundice 117 days after taking a single dose of RG-101, the statement said. The patient, who has end-stage renal disease and was on dialysis, was enrolled in the Regulus ongoing phase 1 US drug trial, according to the company statement.

In a conference call about the FDA action, Paul Grint, President and CEO of Regulus, said that the patient with jaundice had elevated bilirubin lab results and was hospitalized for further evaluation. The patient was later released in stable condition and the study investigator assessed the SAE as unlikely related to RG-101, he said.

The recent SAE was the second case of jaundice involving patients who received RG-101, Grint said. Both patients also had type 2 diabetes and the first SAE occurred earlier his year and involved a patient who also received RG-101 in a Phase 2 trial, he said.

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