Acorda Pauses Enrollment in Phase III Studies of Parkinson’s Candidate after Five Patient Deaths
Acorda Therapeutics said today it has paused enrollment of new patients in its Phase III studies assessing its Parkinson’s disease candidate tozadenant after seven patients treated with the drug developed sepsis—five of whom died.
The enrollment pause will continue pending further talks with the studies’ independent Data Safety Monitoring Board (DSMB) and the FDA, Acorda said.
“Contingent on further input from the DSMB and FDA, we continue to expect to report efficacy and safety results of the double-blind Phase III study in the first quarter of 2018,” Acorda president and CEO Ron Cohen, M.D., said in a statement.
Four of the sepsis cases were associated with agranulocytosis, two had no white blood cell counts available at the time of the event, and one had a high white blood cell count, the company disclosed, without saying how many of the agranulocytosis-associated sepsis cases resulted in death.
In addition to pausing enrollment, Acorda said it has increased the frequency of blood cell count monitoring for patients in the studies. Including an earlier Phase IIb study, approximately 890 patients have been exposed to tozadenant and another 234, to placebo.
“We have taken these steps in the best interests of the safety of patients in the tozadenant studies, which is our top priority,” Dr. Cohen added.
Investors responded to the clinical setback with a selloff that sent Acorda shares sinking nearly 34% in after-hours trading this morning as of 9:15 a.m., to $18.70 from yesterday’s close of $27.70.
Tozadenant is an oral adenosine A2a receptor antagonist being developed as an adjunctive treatment to levodopa in Parkinson’s disease patients to reduce OFF time. A2a receptor antagonists have the potential to be the first new class of drug approved in the U.S. for improvement of motor symptoms in Parkinson’s disease in over 20 years, Acorda reasons.
Acorda Pauses Enrollment in Phase III Studies of Parkinson’s Candidate after Five Patient Deaths
