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Huntington’s disease is a progressive, neurodegenerative disease that affects 30,000 patients in the U.S., with another 150,000 at risk. It is caused by the death of specific brain cells and is characterized by the gradual development of involuntary muscle movements, progressive deterioration of cognitive processes and memory (dementia), and severe behavioral disturbances. No drugs are approved by the FDA to treat this uniformly fatal genetic disorder.
Dimebon has been shown in preclinical studies to protect neurons against the neurotoxic human huntingtin protein, which is the cause of Huntington’s disease. In July 2008, we announced positive safety and efficacy results from our Phase 2 trial of Dimebon for the treatment of Huntington’s disease, which was conducted in collaboration with the Huntington Study Group, a network of clinical trial investigators from academic and research institutions throughout the United States, Canada, Europe and Australia. The three month randomized, placebo-controlled, double-blind study met its primary endpoint of safety and tolerability; in addition, Dimebon showed statistically significant benefit versus placebo in cognition as measured by the Mini Mental State Examination, a secondary endpoint in the study. We plan to continue further development of Dimebon in patients with mild-to-moderate Huntington’s disease based on the positive results seen in the Phase 2 trial.
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