Alzheon has presented new analyses of a Phase 3 trial of tramiprosate, a potential Alzheimer’s disease (AD) treatment.

Tramiprosate is an amyloid anti-aggregation agent and the active molecule of prodrug ALZ-801.

The new analyses solely evaluated tramiprosate in Alzheimer’s patients who were carriers of the homozygous two ε4 alleles of apolipoprotein E gene (APOE4/4 homozygotes), after recently-published data from the Phase 3 trial showed AD patients who carry APOE4/4 responded to the treatment with the largest clinical benefits. 

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The data for APOE4/4 patients was analyzed based on the severity of disease as measured by the Mini–Mental State Examination (MMSE) scores, from the overall Mild and Moderate AD population (MMSE 16-26) to milder groups (MMSE 20-26 and 22-26).

Results showed that tramiprosate was most effective in the least impaired patient group with MMSE scores of 22 to 26. This population had significant responses from tramiprosate in both cognition (measured by ADAS-cog scale) as well as function (measured by CDR-SB scale).

“Our new insights are defining a more targeted, higher probability development path to advance promising drug candidates by directing Alzheimer’s drugs to the right patients, with the right drug, and at the right stage of their disease,” said Martin Tolar, MD, PhD, president and CEO of Alzheon.

A pivotal clinical program for ALZ-801 as a potential disease-modifying treatment for APOE4/4 homozygous patients with mild Alzheimer’s is being planned in 2017. 

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