Neuren Pharmaceuticals

NNZ-2566 has completed non-clinical and Phase 1a and 1b testing for safety and the measurement of pharmacokinetic properties as a neuroprotectant for traumatic brain injury (TBI).The drug will now be tested separately in a Phase 2 clinical trial for TBI commencing in Q4 2009.

Neuren has obtained consistent evidence of the drug’s ability to improve outcomes in multiple animal models of brain injury. The data obtained from these experiments have also revealed the compound’s complex mode of action. NNZ-2566 has been shown to have multi-faceted actions which significantly reduce both inflammation and apoptosis (cell death), protecting the neurons and their surrounding infrastructure, as well as dramatically inhibiting post-injury convulsive and non-convulsive seizures.

NNZ-2566 is being developed in collaboration with the US Army’s Walter Reed Army Institute of Research (WRAIR) and the US Army’s Combat Casualty Care Research Program. In late 2004, Neuren entered into a Material Transfer Agreement with Walter Reed under which the Institute performed preliminary testing of NNZ-2566 in an animal model of traumatic brain injury.

Following positive results from the preliminary studies, Neuren and the Army executed a Cooperative Research and Development Agreement (CRADA) to further develop NNZ-2566 as a therapy for traumatic brain injury. The CRADA subsequently has been amended to include additional studies of non-convulsive seizures and the drug's molecular mechanism of action. Neuren, WRAIR and other Army physicians and scientists are collaborating in the development of clinical trial protocols and regulatory filings for the trials.

The US Investigational New Drug (IND) application for the upcoming NNZ-2566 Phase 2 trial was approved by the US FDA in March 2009. Fast Track designation was granted in June 2009.

For more information about the Phase 2 clinical trial in TBI patients using NNZ-2566, please visit the www.clinicaltrials.gov website.

Clinical Trials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.

At the registry homepage go to ‘Search for Clinical Trials’ and enter ‘Neuren’ in the search field.

NNZ-2566 Development Strategy Overview (click here)