March 19, 2015 | By Márcio Barra
The Bial group announced today that the BIAPARK I phase III clinical trial study evaluating Opicapone, an investigational peripheral COMT inhibitor for people with Parkinson´s Disease, obtained positive results. This is the second new investigational drug developed by Bial, following Zebinix (eslicarbazepine acetate).
Opicapone is a selective and reversible COMT inhibitor, to be used in combination with L-DOPA/ Carbidopa or L-DOPA/benserezide. The drug increases L-DOPA plasma levels when administered alongside L-DOPA, through inhibition of the O-methylation of L-DOPA by the COMT enzyme, thus increasing L-DOPA´s plasma half-life. In the BIAPARK I study, the drug was compared to Entacapone, another COMT inhibitor, and placebo. The study results, which will be presented today at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in France, show that the daily intake of 50 mg of Opicapone led to a significant reduction (2 hours) of the OFF-time period compared to placebo. Moreover, Opicapone was considered overall safe and well tolerated.
Currently, there are two COMT inhibitors available on the market, Tolcapone and Entacapone. Of the two, Tolcapone is the more efficacious, reducing OFF time in 98 minutes when compared to placebo, versus 41 minutes for Entacapone. Tolcapone´s use however, is hindered by its potential hepatic toxicity. Both drugs also require multiple dosages over the day, while Opicapone is once-daily.
Professor Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon, said, “In the last 10 years, there have been few new treatment options in Parkinson’s disease. Opicapone intends to fulfil the need for a more potent COMT inhibitor.”
Professor Andrew Lees, Professor of Neurology at the National Hospital for Neurology and Neurosurgery, London, added, “Opicapone offers an important alternative to the currently available COMT inhibitors, with convenient once-daily dosing.”
The BIPARK I clinical trial recruited a total of 600 patients over 106 study centers spread over Europe, including Portugal.