Medivation's phase 2 study of Dimebon for Alzheimer's meets all five endpoints

By Lisa Kerner

Charlotte, N.C., Sept. 21 - Medivation, Inc. said its proprietary drug for Alzheimer's disease, Dimebon, met all five efficacy endpoints in a six-month randomized, double-blinded, placebo-controlled phase 2 clinical study.

A total of 183 patients with mild to moderate Alzheimer's disease took part in the study conducted at 11 sites in Russia.

Patients treated with Dimebon demonstrated highly statistically significant improvement on the study's primary efficacy endpoint, the Alzheimer's Disease Assessment Scale-cognition, and on the key secondary efficacy endpoint, the Clinical Global Impression of Change.

Dimebon-treated patients also showed improvement on all three of the secondary efficacy endpoints: the Activities of Daily Living, the Neuropsychiatric Inventory and the Mini Mental State Examination.

Placebo-treated patients deteriorated from baseline on all five efficacy endpoints.

Dimebon was well-tolerated, with fewer serious adverse events in Dimebon-treated patients than in placebo-treated patients.

"It is very rare for a phase 2 Alzheimer's disease study to demonstrate significance on all of the primary and secondary endpoints, five in this case, and with strong statistical significance," said Rachelle Doody, Medivation clinical scientific advisory board member and director of the Alzheimer's center at Baylor University, in a news release.

Medivation plans to start a 12-month extension of the phase 2 study later this year.

The company has used less than $20 million of its equity financing in the past two years to achieve positive results in the Alzheimer's study as well as begin programs in Huntington's disease and hormone-refractory prostate cancer.

San Francisco-based Medivation acquires and develops pharmaceutical and medical device technologies.

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