Acorda Therapeutics Inc. (NASDAQ: ACOR) saw its shares drop sharply following an update on its Parkinson’s trial. The company paused new enrollment in the long-term safety studies, pending further discussion with the independent Data Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA). In a sense, Acorda has halted its trial.
The company also increased the frequency of blood cell count monitoring for participants to weekly in its Phase 3 program of tozadenant for Parkinson’s disease. Acorda took this action in response to cases of agranulocytosis (the absence of white blood cells, which fight infection), possibly drug-related, and in some cases associated with sepsis and death.
Unfortunately, there were seven cases of sepsis in patients taking tozadenant and five of those patients died.
The Phase 3 program includes an ongoing pivotal efficacy and safety study (CL05) and two long-term safety studies (CL05 extension and CL06).
Including the previously conducted Phase 2b study, roughly 890 patients have been exposed to tozadenant and 234 have been exposed to placebo. This corresponds to approximately 300 patient years of tozadenant exposure and 75 patient-years of placebo.
Ron Cohen, M.D., Acorda’s president and CEO, commented:
We have taken these steps in the best interests of the safety of patients in the tozadenant studies, which is our top priority. Contingent on further input from the DSMB and FDA, we continue to expect to report efficacy and safety results of the double-blind Phase 3 study in the first quarter of 2018.
Shares of Acorda closed Tuesday at $28.20, with a consensus analyst price target of $26.20 and a 52-week range of $13.60 to $33.00. Following the announcement, the stock was down about 37% at $17.75 in early trading indications Wednesday.