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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. As a result, we are currently evaluating Dimebon in an ongoing Phase 2 trial in patients with Huntington’s disease 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 trial is a three-month, randomized, placebo-controlled, double-blind evaluation of the safety and preliminary efficacy of Dimebon in approximately 90 Huntington’s disease patients. The primary efficacy endpoint is the Unified Huntington’s Disease Rating Scale (UHDRS). Results are expected in the second quarter of 2008.
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