A safety crisis has forced Bristol-Myers Squibb ($BMY) to slam the brakes on a mid-stage study of a hepatitis C drug, threatening the future of a program that was at the heart of a recent $2.5 billion buyout. And as investigators scrambled to see if the heart failure one trial participant suffered indicated a serious toxicity issue that threatened the rest of the group, at least one prominent analyst wasted no time in writing off the program as a lost cause.
Bristol-Myers' shares dropped 7% this morning, shaving billions of dollars off of its market cap.
According to BMS, one of 30 patients in the Phase IIb trial who was taking the top, 200 mg dose of BMS-986094 suffered heart failure. The drug, once dubbed INX-189 before BMS acquired the program in its buyout of Inhibitex, is a nucleotide polymerase inhibitor, one of several "nucs" racing through the clinic as developers pursue an interferon-free combo approach to hepatitis C.
"Although the issue presented in a patient receiving that dose, it doesn't preclude the possibility of issues with other patients at other doses," a spokesperson told Bloomberg. "At this point, we don't know what the cause of the safety issue is. We are taking the time to evaluate information on all patients receiving this compound."
"We recommend that investors assume BMY's [Bristol's] nuc is dead," wrote ISI's Mark Schoenebaum after the news hit, according to a report from Adam Feuerstein at TheStreet, who's been tracking new hepatitis C drugs for years.
BMS-094 had been considered one of the top clinical prospects in the development of a radically new hepatitis C cocktail therapy. Analysts immediately began to start calculating how the blow-up could influence the hot hep C drug development race.
Gilead's ($GILD) GS-7977 is already in late-stage studies and has been put on a fast-track schedule in a combo study with Gilead's in-house NS5a treatment. Idenix ($IDIX), which just got back the rights to its hep C drugs from Novartis ($NVS), has IDX-184 in the clinic. And Vertex ($VRTX) is racing ahead with the early-stage ALS-2200, which it licensed from Alios.
"With patient safety as the priority, the company is undertaking an immediate assessment of all patients in the study and following an evaluation of the patient data, will take appropriate actions," Bristol noted in a release.
- here's the press release
- get the Bloomberg report
- read the story from TheStreet
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"Only in Biotech": Billions Down the Drain as Bristol Myers' Phase II Hep C Study Fails
With input from @JohnCFierce and others