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