New Alzheimer’s therapy scyllo-inositol gets US patent

Scyllo-inositol (ELND005) therapy has received fast-track review status for treating Alzheimer’s disease.

Update: Alzheimer’s drug ELND005 or scyllo-inositol trials suffer setback as 9 patients die: Elan and Transition (16 Dec 2009)

Scyllo-inositol or ELND005 therapy for Alzheimer’s disease developed by Elan Corporation, plc and Transition Therapeutics Inc. received patent from the United States Patent and Trademark Office.

Scyllo-inositol (ELND005) has been granted  US patent number 7,521,481 on April 21, 2009 for “Methods of Preventing, Treating and Diagnosing Disorders of Protein Aggregation,” and generally claims methods for treating Alzheimer’s disease comprising administering scyllo-inositol (ELND005).

The patent for scyllo-inositol will be valid till the year 2025 or later due to any patent term extensions.

Earlier, scyllo-inositol had got fast-track designation from the US Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer’s disease.

Fast track designation facilitates development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions. ELND005 is an orally-administered therapeutic agent.

Scyllo-inocitol, which is currently in Phase 2 clinical trials, is developed through a joint development and commercialization agreement between Elan Pharma and Transition reached in 2005.

The Phase 2 study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 340 patients with mild to moderate Alzheimer’s disease.

Multiple Phase 1 studies that evaluated the safety, tolerability and pharmacokinetic profile of scylla-inositol (ELND005) in approximately 110 healthy volunteers, have found that ELND005 was safe and well-tolerated at all doses and dosing regimens examined.

No severe or serious adverse events were observed.

Scylla-inositol (ELND005) may act through the unique mechanism of preventing and reversing the fibrilization of beta-amyloid, a toxic peptide that forms plaques that are a key pathological feature of Alzheimer’s disease, poreclinical studies suggest.

“The issuance of this patent is an important milestone in the development of ELND005, a unique oral compound with a favourable safety profile that crosses the blood-brain barrier and targets the disaggregation of amyloid beta in the brain,” said Dr. Tony Cruz, chairman and chief executive officer of Transition.

It is currently estimated that 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.

Elan Corporation, plc is a neuroscience-based biotechnology company. Elan shares trade on the New York, London and Dublin Stock Exchanges.

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition’s lead products include ELND005 (AZD-103) 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.

Alzheimer’s Disease

Alzheimer’s disease 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 is a leading cause of dementia.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.