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Home » TRANSITION'S ALZHEIMER'S DRUG TRIAL REPORTS POSITIVE RESULTS
TRANSITION'S ALZHEIMER'S DRUG TRIAL REPORTS POSITIVE RESULTS
August 9, 2006
Transition Therapeutics has announced the results from a Phase I trial of its lead Alzheimer's disease drug product, AZD-103. Thirteen healthy volunteers were dosed in the study to evaluate the pharmacokinetics, safety and tolerability of a single ascending dose of AZD-103. The study showed that AZD-103 has a favorable pharmacokinetic profile that supports the targeted therapeutic dosing levels for the drug. The safety data indicated that it was well-tolerated by all subjects. No safety concerns or significant adverse events were observed in the study.
The clinical development program for AZD-103 consists of a series of Phase I studies to establish the safety, tolerability and pharmacokinetic profile for AZD-103. Building on these results, Transition has received FDA clearance and will commence a Phase I study to examine higher doses of AZD-103. Transition expects to submit an application for a Phase II trial in Alzheimer's disease patients in early 2007.
AZD-103 is part of an emerging class of disease-modifying drugs that have the potential to both reduce disease progression and improve symptoms such as cognitive function. The drug reduces accumulation of amyloid beta plaque in the brain, as well as reduces or eliminates learning deficits in a leading transgenic mouse model of Alzheimer's disease.
KEYWORDS Drug Pipeline Alert
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