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Acorda Therapeutics updated its Phase III clinical trial of tozadenant for Parkinson’s disease. Enrollment has been halted for new patients due to several deaths, and changes in the program have been made related to safety issues.
Tozadenant is an oral adenosine A2a receptor antagonist. It is in development as an adjunctive treatment to levodopa in Parkinson’s disease patients in an effort to reduce OFF time. OFF time refers to the motor fluctuations in Parkinson’s patients when the treatment, usually levodopa, is not working best and symptoms return.
In both the Phase IIb study and the current Phase III study, about 890 patients received tozadenant and 234 have received placebo. There have been five fatalities out of seven patients with sepsis, all in the tozadenant group. Agranulocytosis is an absence of white blood cells, which are key immune cells. Four of the cases of sepsis were related to agranulocytosis, two had no white blood cell counts at the time of the event and one patient had a high white blood cell count.
In addition to pausing enrollment pending further review and discussions with the independent Data Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA), the company has increased the number of times it conducts blood cell counts on participants in the trial.
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