BioCentury
ARTICLE | Clinical News

Alzheon reports Phase I bridging dose analysis data for AD candidate ALZ-801

October 27, 2017 9:41 PM UTC

Based on a bridging dose analysis of 3 placebo-controlled Phase I trials evaluating the safety and pharmacokinetics of various dosing regimens and formulations of Alzheimer’s disease candidate ALZ-801 in 127 healthy volunteers, Alzheon Inc. (Framingham, Mass.) said it found that a twice-daily 265 mg dose of the candidate achieved a steady-state area under the curve (AUC) exposure equivalent to a twice-daily 150 mg oral dose of its parent molecule, tramiprosate. ALZ-801 is an oral small molecule prodrug of tramiprosate, an inhibitor of amyloid formation and neurotoxicity. The twice-daily 150 mg dose of tramiprosate has shown positive cognitive and functional improvements in AD patients who are homozygous for apolipoprotein E epsilon 4 (APOE4) (see BioCentury, Nov. 16, 2015).

ALZ-801 was well tolerated with no serious adverse events reported. Additionally, ALZ-801 given with food reduced the incidence of gastrointestinal symptoms compared to the fasted state, without affecting plasma tramiprosate exposure. Data were published in Clinical Pharmacokinetics. ...

BCIQ Company Profiles

Alzheon Inc.

Bellus Health Inc.

BCIQ Target Profiles

Beta amyloid