Bristol-Myers Squibb, a biopharmaceutical company, has terminated the development of BMS-986094, an investigational NS5B nucleotide for the treatment of hepatitis C.
Based on an ongoing assessment of patients in a Phase II study that the company voluntarily suspended on 1 August 2012, the decision was taken and the FDA consequently placed the compound on clinical hold.
Bristol-Myers executive vice president and chief scientific officer Elliott Sigal said the decision to halt development of BMS-986094 has been taken in interest of protecting patients.
"In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C," Sigal added.
"We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community."
An initial case of heart failure was the basis for halting the study which later resulted in death and to date, nine patients have been hospitalized.
According to the company, the cause of the unexpected events, which involve heart and kidney toxicity, has not been definitively established.
