Alzheon, Inc. announced that it will be presenting baseline imaging characteristics from its ongoing APOLLOE4 Phase 3 clinical trial and new correlation analyses from the Phase 2 Biomarker study evaluating ALZ-801 oral tablet at the upcoming Alzheimer's Association International Conference, to be held from July 16 - 20, 2023 in Amsterdam, Netherlands. ALZ-801 (valiltramiprosate) is an investigational oral disease-modifying therapy in Phase 3 development for the treatment of Early AD. The unique upstream mechanism of action of ALZ-801 has demonstrated the ability to prevent the formation of the soluble neurotoxic oligomers, while avoiding the breakdown of amyloid plaque in blood vessels, and ongoing safety surveillance in clinical trials continues to show no increase in brain edema and bleeds in APOE4/4 homozygous AD patients, who are at the highest risk of symptomatic ARIA with anti-amyloid antibodies.

ALZ-801 tablet is currently being evaluated in two clinical trials in Early AD subjects: the 84-patient Phase 2 biomarker study in APOE4 carriers, including 31 APOE4/4 hom homozygotes, and the fully enrolled pivotal APOLLOE4 phase 3 study in 325 APOE4/4 hom heterozygotes. The 24-month Phase 2 biomarker trial will be completed in the third quarter of 2023, and the topline of 18-month APOLLOE4 Phase3 trial is expected in the third quarter of 2024, with planned NDA filing shortly thereafter and commercial launch in 2025.