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Alzheimer’s disease is a progressive condition that affects areas of the brain involved in memory, cognition, judgment, language and behavior. It is the most common dementia among older adults. In the United States, more than 4 million people suffer from Alzheimer’s disease, with that number expected to grow to 14 million by 2050. Five drugs—with combined sales of approximately $5 billion—are approved in the U.S. to treat Alzheimer’s disease. However, they treat symptoms with only modest effect, and none modify the underlying disease. This underscores the significant unmet medical need in Alzheimer’s disease.
In a randomized, double-blinded, placebo-controlled clinical trial of 183 patients with mild-to-moderate Alzheimer’s disease conducted at 11 sites in Russia, Dimebon improved the clinical course of Alzheimer’s disease patients by causing 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. In addition, after six months of treatment, Dimebon patients were significantly better on all five disease aspects than they were at the beginning of the study. The real world impact of these data was evaluated by independent assessment, including caregiver interviews, which confirmed improvement or stabilization in 81 percent of Dimebon treated patients after six months of treatment. Importantly, Dimebon’s 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, with dry mouth (18.0 percent Dimebon, 1.1 percent placebo) and depressed mood/depression the most common events. There were significantly fewer serious adverse events in the Dimebon group than in the placebo group at one year.
We are not aware of any published Alzheimer’s disease study in which a drug has achieved statistically significant benefits of the breadth, size and duration of those seen in our first pivotal clinical trial of Dimebon.
In January 2008, the FDA informed us that this trial can be used as one of the two pivotal studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease, as long as a significant portion of the sites in our confirmatory pivotal Phase 3 trial are located in the United States. However, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of our preclinical and clinical data, so its views remain subject to change.
We plan to begin our second, confirmatory pivotal Phase 3 Alzheimer’s disease trial in the second quarter of 2008. |
