Neuren Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its investigational new drug application (IND) and authorised the Company to proceed with its Phase 3 trial to prevent cognitive impairment following major cardiac surgery using Glypromate.
Neuren has engaged a US-based, international contract research organisation to manage the global trial of 520 patients which will be carried out in the US, Australia and New Zealand. This Phase 3 trial is double-blind, multi-centred, placebo controlled and 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.
The Phase 3 trial is budgeted to cost Neuren A$10 million, which is substantially less than many other Phase 3 trials.
There are currently no treatments available to prevent cognitive impairment following cardiac surgery, which is experienced by up to 70% of patients at discharge and more than one-third of patients at three months following surgery. Loss of cognitive function has been shown to negatively impact quality of life for cardiac surgery patients and is recognised as an important therapeutic target by the American Heart Association and the American College of Cardiology, and has previously been accepted as a condition requiring treatment by the US FDA.
In 2005, the FDA recommended that Neuren advance Glypromate into a Phase 3 study. Neuren has now successfully completed additional testing of the drug in both volunteers and cardiac surgery patients. The Company believes that authorisation from the FDA to proceed with the planned Phase 3 trial confirms that Neuren’s clinical development program meets international standards and positions Glypromate to be first in a market estimated at US$1 billion.