Pfizer suffers Alzheimer’s setback
pharmafile | March 4, 2010 | News story | Research and Development | Alzheimer's, Medivation, Pfizer
Pfizer has suffered a big setback with the oral Alzheimer’s disease treatment it is developing with biotech outfit Medivation.
Investigational drug dimebon (latrepirdine) has failed to meet both primary and secondary efficacy endpoints in the phase III Connection trial.
The companies were surprised by the results, which Medivation chief executive David Hung admitted were “unexpected”.
“We are working with our colleagues at Pfizer to better understand the Connection data,” he added.
Briggs Morrison, senior vice president of clinical development in Pfizer’s primary care business unit, said: “After that review, Pfizer will be in a position to determine appropriate next steps regarding the dimebon programme.”
In 2008 the companies signed a global agreement to develop and commercialise dimebon for both Alzheimer’s and Huntington disease.
Hung said Medivation was “disappointed for the Alzheimer’s community” but the San Francisco-based firm may also be counting the cost.
Pfizer initially paid it $225 million, but there was a possible $500 million to follow if regulatory milestones are met.
While its tolerability was proved in both Connection and a separate phase III study, the Connection endpoints were measures of cognition and global function.
The six-month, double-blind, placebo-controlled trial of nearly 600 patients took place in North America, Europe and South America.
They were randomised to one of three treatment groups: dimebon 20mg three times a day (TID), 5mg TID, or placebo TID.
No statistically significant improvements for the 20mg TID group relative to placebo were achieved – when it came to cognition, using an approved measure, dimebon-treated patients achieved a 0.1 point difference from placebo.
And as to global function, 64.9% of patients treated with dimebon 20mg TID showed improvement or no change at week 26 compared to 65.4% for placebo.
Patients also showed no significant differences versus placebo on the secondary endpoints, including activities of daily living and behaviour improvement.
Data will be presented at a future meeting, but Morrison said Pfizer remained “committed to advancing treatment options for Alzheimer’s disease” and is currently enrolling patients in four other phase III studies of dimebon.
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