The firm is developing tozadenant, an oral adenosine A2a receptor antagonist, as an adjunctive treatment to levodopa in Parkinson’s disease patients but announced yesterday it was implementing new safety steps and halting trial enrolment following evidence of serious adverse events in a Phase III study.
“Approximately 890 patients have been exposed to tozadenant [in phase IIb and phase III trials in the US and Europe] and we’ve seen seven cases of sepsis, five of which were fatal,” CEO Ron Cohen said on a conference call.
“We had enough cases come in and this no longer looked random, so we have had to delve into it and do something.”
As such, the firm is implementing weekly blood cell count monitoring for participants in its ongoing clinical studies of tozadenant, effective immediately.
Cohen added: “We expect to have detailed talks with the independent DSMB [Data Safety Monitoring Board] and FDA [US Food and Drug Admistration]. We have also paused new enrolment in the long-term safety studies, pending further discussion until these reviews have been completed.”
Pending the outcome of these discussions, Cohen said his firm remains committed to continuing the programme.
Acorda’s share price plummeted to a three-month low, following the announcement.