ELND005 or scyllo-inositol, an Alzheimer’s treatment currently being studied, could be dropped as the experimental treatment has caused 9 deaths and higher number of serious adverse reactions.
Elan Corporation, plc and Transition Therapeutics, Inc. has called for immediate halting of the Phase II study AD201 and open label extension study AD251 for ELND005 or scyllo-inositol.
The AD201 study is evaluating three dose levels of ELND005 or scyllo-inositol compared to placebo in 353 patients.
Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily), Elan said in a press release.
The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily.
“Today’s decision speaks to our strong commitment to patient safety while allowing for the continued evaluation of ELND005 or scyllo-inositol at the 250mg dose, twice daily,” said Menghis Bairu, M.D., EVP, Chief Medical Officer and Head of Global Development at Elan.
ELND005 or scyllo-inositol is an orally-administered drug that has received fast track designation from the U.S. Food and Drug Administration for treatment of mild to moderate Alzheimer’s disease.
ELND005 is currently in a Phase 2 clinical study, which completed enrollment in October 2008. The study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 353 patients with mild to moderate Alzheimer’s disease. The planned treatment period for each patient is approximately 18 months.
The decision by the companies to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study.
Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses.
However, a direct relationship between ELND005 and these deaths has not been established.
The ISMC and both companies concur that the tolerability and safety data are acceptable among patients receiving the 250mg dose and that the blinded study should continue for this dose and the placebo group.
“We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment Alzheimer’s disease.”
Alzheimer’s disease, a leading cause of dementia, is a progressive brain disorder that gradually destroys a person’s memory and ability to learn reason, make judgments, communicate and carry out daily activities.
Alzheimer’s disease may result from the build-up of toxic beta-amyloid peptides in the brain. As Alzheimer’s disease progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.
More than 5 million Americans have Alzheimer’s disease and more than 24 million people worldwide over the age of 60 have some form of dementia according to Alzheimer’s Association and Alzheimer’s Disease International.
Elan Corporation, plc is a neuroscience-based biotechnology company.
Transition is a biopharmaceutical company.Transition’s lead products include ELND005 for the treatment of Alzheimer’s disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates acquired externally and developed internally using its proprietary drug discovery engine.