BMS drops Inhibitex HCV compound

Bristol-Myers Squibb Co. (NYSE:BMY) said late Thursday it discontinued development of BMS-986094 (formerly INX-189) after the nucleotide NS5B polymerase inhibitor was associated with cardiovascular and renal toxicity in a Phase II trial in HCV. Earlier this month, one patient in the trial suffered heart failure, prompting FDA to place a hold on the product. The pharma said Thursday the patient died and eight others have been hospitalized. Two remain in the hospital. Bristol-Myers, which has yet to identify the cause of the adverse events, plans to make information on BMS-986094 available "to inform the development" of other HCV compounds. The pharma gained BMS-986094 in January through its acquisition of Inhibitex Inc. for $2.5 billion (see BioCentury Extra, Aug. 2).

Following the initial adverse event, FDA placed a hold on a similar nucleotide NS5B polymerase inhibitor -- IDX184 -- from Idenix Pharmaceuticals Inc. (NASDAQ:IDIX). FDA asked for additional cardiac data from patients in an ongoing Phase IIb trial. At the time, Idenix said there has been no evidence of cardiotoxicity associated with IDX184. The company added that it believes there are "significant differences" between IDX184 and BMS-986094, specifically that IDX184 uses different pro-drug technology and more specifically targets the liver. On Thursday, Idenix was off $0.16 to $6.09. In early after-hours trading, the stock was off $0.40 to $5.69 (see BioCentury Extra, Aug. 16). ...