Alzheon plans to start a multi-center (U.S. and international) Phase 3 trial in 500 mild APOE4/4 homozygous patients next year, with a second trial to start about six months later. Tolar estimates that 10-15% of all AD patients (about 530,000 people) are APOE4/4 homozygotes. Given that these are the patients with the highest prevalence of brain amyloid, these two studies should give the highest chance of delaying progression of this disease and even enhancing cognitive improvement over the 18 months of this study. Tolar plans to leverage these data along with the original safety results of the earlier 2,000 tramiprosate trial when filing the NDA for ALZ-801 in 2020.
As quoted from Forbes.com. Read the full article here