US biotech firm Alzheon has announced the publication of clinical results demonstrating that ALZ-801 achieved levels of therapeutic efficacy with favorable safety and tolerability profile for use as an orally-administered medicine for the treatment of Alzheimer’s disease.
ALZ-801 is an oral, amyloid-targeted therapy that blocks the formation of toxic beta amyloid oligomers associated with the development and progression of AD. The US Food and Drug Administration has granted Fast Track designation to Alzheon’s lead clinical investigational drug.
These data establish the clinical dose of ALZ-801 of 265mg administered orally twice daily, which correlates with therapeutic levels of the active agent tramiprosate that showed positive cognitive and functional improvements in Alzheimer’s patients with apolipoprotein E4 (APOE4) genotype. The manuscript titled “Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for Treatment of Alzheimer’s Disease” is featured in the advanced online publication of the journal Clinical Pharmacokinetics, and the paper is available through open access at https://link.springer.com/article/10.1007/s40262-017-0608-3.
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