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Acorda Decides Tozadenant Isn’t Salvageable, Moves Primary Focus To Inbrija

 
• By Joseph Haas

Days after revealing seven cases of sepsis in trial participants receiving tozadenant – including five deaths – Acorda terminates development of the Phase III Parkinson’s candidate.

Yellow road sign with a blue sky and white clouds: clinical trial

Despite saying on Nov. 15 that it needed to take a longer review of the data for Phase III Parkinson’s disease candidate tozadenant, Acorda Therapeutics Inc. quickly decided the prudent approach was to pull the plug on the A2a receptor inhibitor due seven cases of sepsis and five deaths seen in treatment-arm patients across Phase IIb and Phase III investigation of the drug.

On Nov. 20, the Ardsley, N.Y.-based firm announced that it has discontinued development of tozadenant, ceasing dosing in the pivotal CL05 study as well as a pair of long-term safety trials – CL05 extension and CL06. While announcing five deaths of patients who had received tozadenant due to agranulocytosis and associated severe adverse events on Nov. 15, Acorda told an investor call that it had increased the frequency of blood monitoring in CL05

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