Understanding the Safety Profile of ALZ-801 in High-Risk Alzheimer Disease: Susan Abushakra, MD


The chief medical officer of Alzheon detailed the phase 2 safety findings of ALZ-801, and the lack of amyloid-related imaging abnormalities observed. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

"Out of 84 patients, 75 have completed imaging at 1 year, and most of them are now a year and a half into treatment. So far, not a single case of ARIA-E. The safety profile remains very consistent with all prior data."

In recent years, there has been a trend towards development of therapies that specifically target amyloid-ß plaques in the earliest stages of patients with Alzheimer disease (AD). After years of failed trials, the FDA approved aducanumab (Aduhelm; Biogen) in June 2021, and could potentially approve another agent—lecanemab (Eisai/Biogen)—in January 2023. Amyloid-related imaging abnormalities (ARIA) results from treatment-related loss of vascular integrity and may occur in 2 forms: with edema or effusion and with hemorrhage.

ALZ-801, an investigational medication developed by Alzheon, is currently being assessed in a phase 2 biomarker study and a phase 3 placebo controlled trial called APOLLOE4. At the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, November 29 to December 2, in San Francisco, California, the company released positive interim data from the biomarker study, with the agent showing significant, progressive, and sustained reduction of phosphorylated tau 181, reaching a robust change 41% reduction at 52 weeks. In addition to performing well on other biomarkers such as amyloid-ß 42/40 and brain atrophy, the therapeutic demonstrated favorable safety, with low risk of ARIA-E.

Susan Abushakra, MD, chief medical officer of Alzheon, sat down with NeurologyLive® at the conference to discuss the findings, specifically the safety profile. She discussed the data from the phase 2 trial, as well as previous observations from the old formulation of the drug. Additionally, she touched upon the lack of ARIA-E observed, and why ALZ-801 has therapeutic potential going forward.

Click here for more coverage of 2022.

1. Abushakra S, Hey J, Bennow K, et al. Significant effects of oral ALZ-801 on plasma biomarkers of Alzheimer’s disease: 12-month interim analysis of phase 2 biomarker study in APOE4 carriers with early AD. Presented at: 2022 CTAD Conference; November 29-December 2; San Francisco, CA. Abstract OC27
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