FDA clears phase I trial for Alzheimer's drug
Toronto, Canada-based biopharmaceuticals firm Transition Therapeutics has received clearance from the US Food and Drug Administration (FDA) to initiate a phase I clinical trial for its lead Alzheimer's drug product, AZD-103.
Toronto, Canada-based biopharmaceuticals firm Transition Therapeutics has received clearance from the US Food and Drug Administration (FDA) to initiate a phase I clinical trial for its lead Alzheimer's drug product, AZD-103.
The phase I trial is a single blind, randomised, placebo controlled study in which healthy volunteers will receive a placebo or an escalating acute dose of AZD-103. The primary objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of AZD-103 and enrolment is expected to begin in September 2006.
The lead compound AZD-103 (scyllo-cyclohexanehexol) is one of an emerging class of disease-modifying drugs that have the potential to both reduce disease progression and improve symptoms such as cognitive function.
Oral treatment of AZD-103 reduces accumulation of amyloid beta and amyloid beta plaques in the brain, as well as reduces or eliminates learning deficits in a leading transgenic mouse model of Alzheimer's disease, Transition says.