Posted by Michael Wonder on 24 Oct 2017
FDA grants fast track designation to Alzheon’s ALZ-801 development program for the treatment of Alzheimer’s disease
24 October 2017 - Company’s phase 3 clinical program pioneers a precision medicine approach in Alzheimer’s disease.
Alzheon today announced that the U.S. FDA has granted Fast Track designation to its lead clinical investigational drug, ALZ-801, for the treatment of Alzheimer’s disease (AD).
Alzheon is implementing a precision medicine approach for treating Alzheimer’s disease by evaluating ALZ-801 based on genetic markers and stage of the disease. The initial 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 AD. Future clinical plans include expanding the evaluation of ALZ-801 in additional populations of AD patients. To date, there are no approved drugs that target the underlying pathology, and slow the progressive cognitive and functional decline of Alzheimer’s disease.
