Alzheimer’s Drug Put on Fast Track
The FDA conferred fast-track status on an Alzheimer’s disease drug from Alzheon.
The drug, ALZ-801, is an optimized prodrug of tramiprosate that has shown promise in clinical trials, the company said.
The forthcoming Phase 3 program for ALZ-801 will focus initially on a genetically-defined group of high-risk patients who are homozygous for the ε4 allele of apolipoprotein E (APOE4/4 homozygotes) in the mild stage of the disease. The target population could be expanded in further investigations of the treatment.