Concerns over patient safety have prompted New York-based Bristol-Myers Squibb Co. to discontinue a mid-stage study of its hepatitis C treatment BMS-986094.
Nine patients in the trial were hospitalized, including one who died of heart failure. Two patients remain under hospital care, the drug maker said. “The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients,” said Elliot Sigal, its chief scientific officer.
Though BMS said it has not yet determined exactly what caused the patients to become ill, heart and kidney toxicity are likely a key factor. BMS pledged it would continue to look into the matter. Meanwhile, the Food and Drug Administration has placed BMS-986094 on a clinical hold, and FDA and the drug maker are monitoring the study patients.
BMS-986094 was one of two key experimental hepatitis C treatments in BMS’ portfolio. The other, the compound daclatasvir, has begun late-stage testing. BMS acquired BMS-986094 along with other potential treatments as part of its acquisition of drug developer Inhibitex Inc. earlier this year.
FDA has focused more on experimental drugs’ cardiovascular risks since Merck & Co.’s agency-approved painkiller Vioxx was found to double the risk of heart attack or stroke.
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