Medivation Initiates Second Pivotal Phase 3 Trial Of Dimebon™ In Patients With Alzheimer's Disease

[Source: Genome Web News] - 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.

"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."

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.

Design of CONNECTION Study

The CONNECTION study will enroll approximately 525 patients with mild-to-moderate Alzheimer's disease at approximately 100 sites in the United States, Europe and South America. Patients will be randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo. Patients may not be taking any other Alzheimer's disease drugs during the trial. After completing six months of treatment, all patients - including those randomized to placebo - will be offered the opportunity to receive Dimebon in an extension trial until marketing authorization.

The primary endpoints of the trial are the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change plus caregiver interview (CIBIC-plus). These are the two endpoints that have been accepted by the FDA to support registration of all approved drugs for Alzheimer's disease.

Pierre Tariot, M.D., Director, Memory Disorders Center, Banner Alzheimer's Institute. "There is an urgent need for new treatments for a disease with such devastating effects on the quality of life of patients and their caregivers. Dimebon represents an innovative form of therapy that may have the potential to ameliorate symptoms and possibly improve the course of Alzheimer's disease. It is crucial that it be fully assessed as rapidly as possible."

For more information on the CONNECTION study, please visit
http://www.connectionstudy.com.

Results of First Pivotal Phase 3 Trial

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.