trial was halted earlier this month.
Since then, that patient died and eight others were hospitalized for “heart and kidney toxicity,” BMS said, noting that two patients remained in the hospital. Some 90 patients were enrolled in the dose-ranging trial, which included a placebo group in its four treatment arms.
The fatal heart failure case occurred in a patient assigned to the highest dose of BMS-986094. Doses given to the eight other patients who were hospitalized were not disclosed.
“While the cause of these unexpected events … has not been definitively established, the company has determined that it is in the best interest of patients to halt development of BMS-986094,” according to the company statement.
Last week, the FDA put a partial hold on a trial of another HCV nucleotide polymerase inhibitor, IDX184, under development by Idenix Pharmaceuticals, citing the heart failure case seen with the BMS product.
Idenix said its drug, which had been coadministered with the standard HCV regimen of ribavirin and pegylated interferon, had not shown any cardiotoxicity beyond that expected with the other agents.
Idenix said it was told to provide the FDA with electrocardiograms on 67 patients who had received the drug in its trials. No patients were currently being dosed with the agent, the company said.
BMS promised to investigate the safety issue with its drug, including studies to determine the potential toxic mechanism.
“The company will continue close monitoring and follow-up of patients who have received BMS-986094 across all studies,” it added.Add Your Knowledge ™
John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!
Article source: http://www.medpagetoday.com/InfectiousDisease/Hepatitis/34359