BMS suspends dosing in HCV trial
Bristol-Myers Squibb Co. (NYSE:BMY) said it suspended dosing in a Phase II trial of BMS-986094 (formerly INX-189) for HCV after one patient receiving a 200 mg dose in combination with the company's daclatasvir suffered heart failure. Bristol-Myers said it is unknown what caused the safety issue and whether it is related to BMS-986094, a phosphoramidate nucleotide analog NS5B polymerase inhibitor. The company is conducting an assessment of all patients in the trial, which has enrolled about 30 of a planned 120 patients. Bristol-Myers would not disclose how many patients have received BMS-986094 in the compound's clinical development program, but said the product has been evaluated in "several" Phase I trials. Daclatasvir, an HCV NS5A inhibitor, is in Phase III testing for HCV.
The news sent shares of Bristol-Myers sliding $3.05, or 9%, to $32.55 on Thursday. The move translates to a loss in market cap of $5.1 billion. Bristol-Myers' cap is now $54.7 billion. BMS gained BMS-986094 in January through its acquisition of Inhibitex Inc. for $2.5 billion (see BioCentury, Jan. 16). ...