When added to optimal therapy, low doses of the investigational drug enoximone do not reduce the risk of death or hospitalisation in patients with advanced heart failure, according to results of the Phase III ESSENTIAL study presented on 4 September at the European Society of Cardiology meeting in Stockholm.
This will be disappointing news for Myogen, especially as patients themselves did not report any improvement in their symptoms following treatment with enoximone compared to placebo. However, ESSENTIAL demonstrated that low-dose enoximone is as safe and well tolerated as placebo - a contrary finding from other studies, in which high doses of similar agents increased the risk of death compared to placebo.
Myogen can also draw comfort from a suggestion of benefit from treatment with enoximone in patients with poorer heart function (based on ejection fraction) and in those treated for longer than 16 months. However, further studies will be needed to convince the regulators that enoximone has a role in severe heart failure.
By Sue Lyon in Stockholm.