Amyloid

Dimebon improved the clinical course of Alzheimer's

Medivation, Inc. (NASDAQ: MDVN) announced it has initiated dosing of patients in its second pivotal Phase 3 trial of the investigational drug Dimebon™ in patients with mild-to-moderate Alzheimer's disease (AD). The international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon is known as the CONNECTION study. Dimebon is an orally-available small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's disease and Huntington's disease, making it a potential treatment for these and other neurodegenerative diseases. Preclinical data generated to date suggest that Dimebon operates through a novel mitochondrial mechanism of action.

"We saw very encouraging results in our first pivotal trial, in which Dimebon demonstrated statistically significant improvements over placebo on all five efficacy endpoints at both six months and at one year. We look forward to confirming the efficacy and safety of Dimebon in the CONNECTION study," said Lynn Seely, M.D., Chief Medical Officer of Medivation. "The initiation of this study brings us a major step closer to our goal of obtaining regulatory approval for Dimebon. We are working to bring this investigational drug to market as quickly as possible to address the unmet medical need in Alzheimer's disease and bring hope to patients and caregivers." Medivation previously announced results from its first pivotal trial of Dimebon in 183 patients with mild-to-moderate Alzheimer's disease, which showed that Dimebon improved the clinical course of Alzheimer's disease by demonstrating statistically significant improvements over placebo in each of the five primary aspects of the disease - memory, thinking, activities of daily living, behavior and overall clinical function. Significant gains over placebo were evident after as little as 12 weeks of treatment, and were maintained after both six months and a full year of treatment. Importantly, overall benefit compared to placebo continued to increase over time, and was larger at one year than at six months. Dimebon was well-tolerated throughout the entire one-year treatment period. The majority of adverse events were mild. Dry mouth (18.0 percent Dimebon, 1.1 percent placebo) and depressed mood were the most common events. Patients treated with Dimebon experienced significantly fewer serious adverse events than those treated with placebo at one year.

The U.S. Food and Drug Administration (FDA) has informed Medivation that the CONNECTION study together with the previously completed pivotal trial can be used to support the approval of Dimebon to treat mild-to-moderate Alzheimer's disease, as long as a significant proportion of the sites in the CONNECTION study are located in the United States. Medivation expects to complete the CONNECTION study and apply for U.S. and European marketing approval in 2010. ... J Pharmacol Exp Ther. 2008 Jun 10