Patient death halts BMS hep C trial
pharmafile | August 30, 2012 | News story | Sales and Marketing | BMS, HCV, hepatitis C
Bristol-Myers Squibb has admitted that the death of a patient was behind its decision to stop development of a potential treatment for hepatitis C.
Earlier this month the company had declined to give details for its decision to voluntarily cease work on the investigational nucleotide polymerase (NS5B) nucleotide BMS-986094.
BMS has now confirmed that it halted the phase II study after an initial case of heart failure, which has since resulted in death.
Another eight patients involved in the trial have been hospitalized due to issues arising from heart and kidney toxicity. Two people remain in hospital.
BMS says the cause of these ‘unexpected events’ has not yet been established and it is working with US regulators and clinical study investigators to conduct ‘close follow-up’ of all BMS-986094 study patients.
The Food and Drug Administration has already placed the compound on clinical hold and BMS says it will share data with other companies developing similar hepatitis C drugs in a bid to reduce risk.
“The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients,” said BMS chief scientific officer Elliott Sigal.
“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,” he added.
The efforts to establish the safety of BMS-986094 will include studies looking at the potential mechanism of the toxicity which has so affected patients.
BMS gained the pill in a $2.5 billion acquisition of Inhibitex earlier this year and had high hopes for it since NS5B inhibitors are set to take a large market share from existing injectable interferon treatments, which include Roche’s Pegasys and Merck’s PegIntron
New oral protease inhibitors already on the market include Johnson and Johnson/Vertex’s Incivek (telaprevir), and Merck’s Victrelis (boceprevir), both of which were launched in the US and Europe last year.
Adam Hill
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