Alzheon, Inc. announced that it will be presenting at the 2022 Alzheimer's Association International Conference (AAIC) to be held on July 31 – August 4, 2022 in San Diego, California, USA. The AAIC presentation: Effects of Oral ALZ-801, an Amyloid Oligomer Inhibitor, on Plasma Biomarkers in APOE4 Carriers with Early Alzheimer's Disease: Results of Six-month Interim Analysis from a Phase 2 Biomarker Study, will provide an opportunity to hear from Dr. Abushakra as she discusses the development strategy and path to New Drug Application (NDA) for the ALZ-801 (valiltramiprosate) program. The presentation will also review the anti-amyloid oligomer mechanism of action of ALZ-801, interim biomarker data from the 6-month interim analysis of Alzheon's fully enrolled Phase 2 biomarker study, and updates on the ongoing pivotal APOLLOE4 Phase 3 trial evaluating ALZ-801 oral tablet in Alzheimer's patients.

ALZ-801 (valiltramiprosate) is an oral agent in Phase 3development as a disease modifying treatment for AD that blocks the formation of neurotoxic soluble amyloid oligomers that lead to cognitive decline in Alzheimer's patients. In mechanism of action studies, ALZ-801 has been shown to fully inhibit the formation of amyloid oligomers at the Phase 3 clinical dose. ALZ-801 has demonstrated potential for robust efficacy and favorable safety in the high-risk Alzheimer's population – patients with two copies of the apolipoprotein e4 allele (APOE4/4).

ALZ-801 is in a class of its own as an easy to administer oral tablet that has shown the potential for robust efficacy with a favorable safety profile, avoiding the vascular complications of brain edema seen with infusions of plaque-clearing anti-amyloid antibodies. The ongoing, fully enrolled Phase 2 biomarker study is evaluating oral ALZ-801 in Early AD patients, who carry either one or two copies of the e4 allele of apolipoprotein E gene. Patients with these genotypes together constitute 65-70% of patients with Alzheimer's disease.

APOE4 genotype, the leading risk factor for Alzheimer's after aging, is associated with a several-fold higher brain burden of neurotoxic amyloid oligomers. About ALZ-801; ALZ-801 is an oral agent in Phase 3development as a potentially disease modifying treatment for AD.1,3 In mechanism of action studies, ALZ-801 has been shown to fully inhibit the formation of neurotoxic soluble amyloid oligomers at the Phase 3 clinical dose.5,6 ALZ-801 acts through a novel enveloping molecular mechanism of action to fully block formation of neurotoxic soluble amyloid oligomers in the human brain7 associated with the onset of cognitive symptoms and progression of AD.1–4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017. The clinical data for ALZ-801 and Alzheon's safety database indicate a favorable safety profile.5–7,9 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with the APOE4/4 genotype, with future expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.1–4 ALZ-801 APOLLOE4 Phase 3 Study; An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This ongoing study is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with the APOE4/4 genotype, who constitute approximately 15% of Alzheimer's patients.

This is a double-blind, randomized trial comparing oral ALZ-801 to placebo treatment over 78 weeks. The APOLLOE4 trial is supported by a $47 million grant from the National Institute on Aging. ALZ-801 Phase 2 Biomarker Study: Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease (NCT04693520): This ongoing study is designed to evaluate the effects of 265 mg twice daily oral dose of ALZ-801 on biomarkers of Alzheimer's pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotypes, who together constitute 65-70% of Alzheimer's patients.

The study also includes evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic profile of ALZ-801 over 104 weeks of treatment.