BMS Discontinues Development of Hep-C Drug

Bristol-Myers Squibb has discontinued development of BMS-986094 (INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C. This decision was made based on safety concerns from the ongoing assessment of patients in a Phase II study. An initial case of heart failure resulted in the death of a patient. The FDA subsequently placed the compound on clinical hold.
 
The company will take a $1.8 billion writedown related to the cancellation. The candidate came over as the key part of BMS’ $2.5 billion acquisition of Inhibitex that closed in February 2012.
 
BMS is working in collaboration with the FDA to conduct comprehensive assessments and follow-up of all BMS-986094 study patients. To date, nine patients have been hospitalized, including the initial patient; two patients remain hospitalized. These events involve heart and kidney toxicity, which have not yet been definitively established.
 
“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.”