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This excerpt taken from the ELN 20-F filed Feb 26, 2009. ELND005,
an Aß aggregation inhibitor
In 2006, Elan entered into an exclusive, worldwide collaboration
with Transition for the joint development and commercialization
of a novel therapeutic agent for Alzheimer’s disease.
The small molecule, ELND005, is a beta amyloid anti-aggregation
agent that has been granted fast track designation by the FDA.
Preclinical data suggest that ELND005 may act through the unique
mechanism of preventing and reversing the fibrilization of beta
amyloid (the aggregation of beta amyloid into clumps of
insoluble oligomers), thus enhancing clearance of amyloid and
preventing plaque deposition. Daily oral treatment with this
compound has been shown to prevent cognition decline in a
transgenic mouse model of Alzheimer’s disease, with reduced
amyloid plaque load in the brain and increased survival rate of
these animals.
Table of Contents
In 2007, it was announced that multiple Phase 1 clinical studies
had been completed, which assessed the safety, tolerability and
pharmacokinetic profile of this compound. In these studies,
ELND005 was found to be safe and well-tolerated at all doses and
dosing regimens examined. No severe or serious adverse events
were observed. ELND005 was also shown to be orally bioavailable,
cross the blood-brain barrier and achieve levels in the brain
and cerebral spinal fluid shown to be effective in animal models
of Alzheimer’s disease.
In December 2007, Elan and Transition announced that the first
patient had been dosed in a Phase 2 clinical study. This
18-month,
randomized, double-blind, placebo-controlled, dose-ranging study
will evaluate the safety and efficacy of ELND005 in
approximately 340 patients with mild to moderate
Alzheimer’s disease.
In October 2008, Elan and Transition announced that the patient
enrollment target for this study had been achieved with
353 patients enrolled.
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