Bristol-Myers
Squibb Company (NYSE: BMY) announced today that the Company has
discontinued development of BMS-986094 (formerly known as INX-189), a
nucleotide polymerase (NS5B) inhibitor that was in Phase II development
for the treatment of hepatitis C. This decision was made in the interest
of patient safety, based on a rapid, thorough and ongoing assessment of
patients in a Phase II study that the Company voluntarily suspended on
August 1, 2012. The U.S. Food and Drug Administration (FDA) subsequently
placed the compound on clinical hold.
The initial case of heart failure, which was the basis for halting the
study, subsequently resulted in death. The Company is working in close
collaboration with the FDA and clinical study investigators to conduct
ongoing, comprehensive assessments and close follow-up of all BMS-986094
study patients. To date, nine patients have been hospitalized, including
the initial patient; two patients remain hospitalized. While the cause
of these unexpected events, which involve heart and kidney toxicity, has
not been definitively established, the Company has determined that it is
in the best interest of patients to halt development of BMS-986094.
"The decision to halt development of BMS-986094 has been guided by our
overriding interest in protecting patients," said Elliott
Sigal, M.D., Ph.D., Executive Vice President and Chief Scientific
Officer, Bristol-Myers Squibb. "In the interest of all patients
participating in hepatitis C clinical studies, and in cooperation with
the FDA, we will make relevant information on BMS-986094 available to
inform the development of other investigational compounds to treat
hepatitis C. We will also work expeditiously to share the results of our
further investigations more broadly in the medical and scientific
community."
Bristol-Myers Squibb is committed to investigating this safety issue
further, including studies to evaluate the potential mechanism of this
toxicity. The Company will continue close monitoring and follow-up of
patients who have received BMS-986094 across all studies.
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