Alzheimer Disease Drug Candidate Granted Fast Track Status
ALZ-801 is an oral anti-amyloid drug that is an optimized prodrug of tramiprosate.
Alzheon announced that its investigational agent for the treatment of Alzheimer disease, ALZ-801, has been granted Fast Track designation.
ALZ-801 is an oral anti-amyloid drug that is an optimized prodrug of tramiprosate; the drug works by blocking the formation of toxic amyloid oligomers associated with Alzheimer disease development and progression.
The company stated in a press release that their pivotal Phase 3 program for ALZ-801 will focus on approval in the genetically-defined subpopulation of high risk patients who are homozygous for the ε4 allele of apolipoprotein E (APOE4/4 homozygotes) at the mild stage of Alzheimer disease.
“We have built a strong body of original research and clinical analyses that support the initial evaluation of ALZ-801 in the genetically-defined high risk population of APOE4/4 homozygotes, enabling us to pioneer a precision medicine approach to Alzheimer's,” said Martin Tolar, MD, PhD, CEO of Alzheon.
The company stated that the clinical program for ALZ-801 may be expanded to additional Alzheimer disease populations in the future.
FDA grants fast track designation to Alzheon's ALZ-801 development program for the treatment of Alzheimer's disease [press release]. Framingham, MA: Alzheon. Published October 24, 2017. Accessed November 9, 2017.