Phase III trial of oral ALZ 801 in patients with early Alzheimer's disease

Privately-held US neurology specialist Alzheon today announced the dosing of the first patient in its APOLLOE4 Phase III study evaluating the efficacy and safety of ALZ-801 in early AD patients carrying two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes).

AD patients with this genetic profile present with an early onset and rapid progression of the disease and are responsive to drug agents that remove or inhibit pathogenic amyloid oligomers. ALZ-801 is an oral treatment that has been shown in pre-clinical mechanistic studies to fully inhibit the formation of neurotoxic soluble beta amyloid oligomers at the Phase III clinical dose.

Alzheon’s announcement comes just ahead of the much-anticipated upcoming US Food and Drug Administration decision on Biogen’s (Nasdaq: BIIB) aducanumab, the most advanced AD candidate, which is expected on Monday.