
Bristol-Myers Squibb halts Hep C pill study
pharmafile | August 2, 2012 | News story | Research and Development, Sales and Marketing | BMS, hepatitis C, pill, trial suspension
Bristol-Myers Squibb has halted a mid-stage trial of a new Hepatitis C drug due to major safety concerns.
In a short statement the company said it has suspended study drug administration in an ongoing Phase II study of BMS-986094 (formerly known as INX-189).
This is an investigational treatment in a new class of nucleotide polymerase (NS5B) inhibitors for the treatment of hepatitis C.
“This voluntary action was taken to protect patient safety based on the emergence of a serious safety issue,” BMS said – it is being reported by Bloomberg that a patient on the trial suffered from heart failure, but this has not been confirmed by BMS.
The firm added that the cause of the safety issue and any potential relationship to study drug are ‘unknown at this time’.
BMS will now undertake an “immediate assessment of all patients in the study” and following an evaluation of the patient data, will take appropriate actions.
New oral protease inhibitors are already on the market, and include Johnson and Johnson/Vertex’ Incivek (telaprevir), and Merck’s Victrelis (boceprevir), both of which were launched in the US and Europe last year.
BMS’ drug is currently in mid-stage development, and it gained the pill in a $2.5 billion acquisition of Inhibitex earlier this year.
These NS5B inhibitors are set to take a large market share from existing injectable interferon treatments, which includes Roche’s Pegasys and Merck’s PegIntron
Ben Adams
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