FDA Grants Fast Track Status to Alzheon’s Alzheimer’s Therapy Candidate ALZ-801

FDA Grants Fast Track Status to Alzheon’s Alzheimer’s Therapy Candidate ALZ-801
The U.S. Food and Drug Administration has granted Fast Track status to Alzheon’s Alzheimer's therapy candidate ALZ-801, which studies have shown prevents the clustering of harmful proteins associated with the disease. “We look forward to working closely with the FDA as we seek to make progress in developing a disease-modifying treatment for Alzheimer’s disease to address the needs of Alzheimer’s patients and their families who struggle with this devastating disease,” Dr. Martin Tolar, Alzheon's president and chief executive officer, said in a press release. Fast track status helps a company accelerate its development of a therapy and obtain faster regulatory review. ALZ-801 prevents the formation and clustering of harmful proteins that play a role in the development of Alzheimer’s. It does this by releasing the nerve-cell-protecting compound tramiprosate, which travels to the brain to prevent harmful protein clustering. Studies in mice have shown that tramiprosate can reduce by 30 percent the amount of amyloid plaque that forms in the brain. Some genes are associated with the development of Alzheimer's. About 65 percent of patients have at least one copy of the APOE4 gene — from either their mother or father — and 10 to 15 percent h
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