Clinical Trial Results of Dimebon Are Disappointing
January 21, 2012
Two partnering drug companies have decided to shelve development of an anti-Alzheimer's therapeutic, Dimebon, following the results of a second disappointing clinical trial. "While the results were not particularly surprising to the research community, this report has underscored the difficulty of creating therapies against Alzheimer's disease," says Guy Eakin, Ph.D., Vice President of Scientific Affairs at the BrightFocus Foundation. "As our nation works to develop a coordinated plan against Alzheimer's, results like these highlight the need for research funding designed to propel new ideas towards the therapeutic pipeline." While the Dimebon product showed promise in earlier Phase 2 clinical trials conducted in Russia, the two more recent Phase 3 trials have failed to show differences between study participants who took Dimebon and those who took a placebo.
View the press release from Pfizer below.
Medivation, Inc.and Pfizer Inc. announced in January the results from the CONCERT trial, which is a Phase 3 trial that evaluated Dimebon (latrepirdine) when added to ongoing treatment with (Aricept) donepezil HCL tablets in patients with mild-to-moderate Alzheimer's disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale—cognitive subscale (which measures cognitive ability, or the Alzheimer's Disease Cooperative Study – Activities of Daily Living, which measures self care and daily function.
“We are disappointed in the CONCERT results and the implications for Alzheimer's disease patients and their caregivers,” said David Hung, M.D., president and CEO of Medivation. “I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial.”
Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.
Medivation and Pfizer will discontinue development of Dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer's disease. The companies also announce that they will terminate their collaboration to co-develop and market Dimebon pursuant to the terms of their Collaboration Agreement.
“We recognize Alzheimer's is a very complex disease,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “Despite this disappointing result, Pfizer remains committed to advancing the science of Alzheimer's disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients.”
The Phase 3 CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with Alzheimer's disease. Patients on a stable dose of donepezil for at least four months were randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo.
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