NEUREN TO BEGIN COGNITIVE IMPAIRMENT THERAPY TRIAL

Neuren Pharmaceuticals announced that the FDA has accepted its investigational new drug application and authorized the company to proceed with its Phase III trial of Glypromate to prevent cognitive impairment following major cardiac surgery.

Neuren has engaged a U.S.-based, international contract research organization to manage the global trial of 520 patients, which will be carried out in the U.S., Australia and New Zealand. This double-blind, multicenter, placebo-controlled trial is based on endpoints that have been well-established in previous FDA-approved studies using validated measurement techniques. The trial is estimated to take 18 months.

There are currently no treatments available to prevent cognitive impairment following cardiac surgery, which is experienced by up to 70 percent of patients at discharge and more than one-third of patients at three months following surgery, according to Neuren. Loss of cognitive function has been shown to negatively affect quality of life for cardiac surgery patients and is recognized as an important therapeutic target by the American Heart Association and the American College of Cardiology, the company said.

In multiple studies in animals, Neuren has demonstrated that Glypromate can significantly reduce brain damage when it is administered up to seven to 11 hours after the initial injury. Glypromate also protects multiple types of brain cells via a unique set of biological actions, protecting the physical structure around the brain's neurons as well as the neurons themselves.