Altering Alzheimer Care Landscape With New, Advanced Therapeutics: Martin Tolar, MD, PhD

WATCH TIME: 10 minutes

"This is the dawn of the new era of neurodegeneration... not only to treat the patients who had the terminal disease, but prevent it and actually intervene much earlier."

Alzheon’s ALZ-801 is a potential first-in-class, investigational oral agent in phase 3 development as a potential treatment for Alzheimer disease (AD). Otherwise known as APOLLOE4, the phase 3 trial (NCT04770220) assessing ALZ-801 focuses on patients with early AD who have 2 copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes). The therapy is designed to block the formation of neurotoxic soluble beta amyloid oligomers implicated in cognitive decline in patients with AD. In studies, ALZ-801 has revealed potential for robust clinical efficacy and favorable safety results with no increased risk of brain vasogenic edema.¹

According to a recent announcement, the company will present 2 oral sessions and 2 posters at the upcoming 2024 Alzheimer’s Association International Conference, held July 28 to August 1, in Philadelphia, Pennsylvania. In a late breaker podium presentation, Aidan Power, MB, MSc, MRCPsych, chief development officer at Alzheon, will give a talk on baseline characteristics and prevalence of comorbid cerebral amyloid angiopathy in the aforementioned phase 3 trial. Susan Abushakra, MD, chief medical officer at Alzheon, will also give a talk on the phase 2 biomarker study (NCT04693520), which assessed plasma biomarkers, hippocampal volume, and cognitive effects of ALZ-801.²

At the meeting, John Hey, PhD, chief scientific officer at Alzheon, will present regulatory basis and statistical considerations from the use of an external comparator-arm, data from the Alzheimer’s Disease Neuroimaging Initiative noninterventional study, tested in the phase 2 study. The company's final presentation at the conference will be given by Patrick Kesslak, PhD, senior clinical research fellow at Alzheon, who will talk about the low incidence of amyloid related imaging abnormalities seen over 104 weeks of treatment in the previously completed phase 2 study.

Months before the conference, Martin Tolar, MD, PhD, the founder, president and CEO at Alzheon, sat down with NeurologyLive^® in an interview to discuss the proposed unifying theory for neurodegenerative diseases and how intervention with small molecules, such as with therapies like ALZ-801, can potentially impact the progression of these conditions. Furthermore, he talked about the implications of early diagnosis and intervention for patients in the pre-symptomatic stages of other neurodegenerative diseases beside AD.

REFERENCES
1. A Two Peer-Reviewed Scientific Publications Describe Fluid Biomarker, Brain Preservation and Clinical Benefits Following 2 Years of Treatment in Phase 2 Trial Evaluating Oral ALZ-801/Valiltramiprosate in APOE4 Carriers with Early Alzheimer’s Disease. News release. Alzheon. June 25, 2024. Accessed July 23, 2024. https://alzheon.com/two-peer-reviewed-scientific-publications-describe-fluid-biomarker-brain-preservation-and-clinical-benefits-following-2-years-of-treatment-in-phase-2-trial-evaluating-oral-alz-801-valiltramiprosate-i/
2. Alzheon to Present Phase 2 Biomarker Trial Results and Baseline Characteristics from APOLLOE4 Phase 3 Trial of Oral ALZ-801/Valiltramiprosate in Patients with Early Alzheimer’s Disease at Alzheimer’s Association International Conference. News Release. Alzheon. Published July 23, 2024. Accessed July 23, 2024. https://alzheon.com/alzheon-to-present-phase-2-biomarker-trial-results-and-baseline-characteristics-from-apolloe4-phase-3-trial-of-oral-alz-801-valiltramiprosate-in-patients-with-early-alzheimers-disease-at-alzh/