Neuren Pharmaceuticals (ASX:NEU) has revealed the grant awarded for supporting its collaboration with the US Army on the development of potential therapies for traumatic brain injury has been increased by US$3 million and extended to 31 December 2015.
Neuren expects to receive the additional grant amount over the next 12 months.
The grant provides funding towards Neuren’s third party costs associated with the Phase 2 clinical trial of NNZ-2566 in moderate to severe traumatic brain injury and the Phase 2 clinical trial of NNZ-2566 in concussion.
The approval of the extension and increase to the grant award is critical to enable Neuren to proceed fully with its strategy to accelerate enrolment of subjects into the trial.
Up to 10 additional trauma centres in the United States will begin enrolment of subjects during the second half of 2014, after approval for each centre is received from the Human Research Protection Office of the US Army Medical Research and Materiel Command.
The rate of enrolment at the existing 12 trauma centres in the United States has already increased significantly in recent months, following the completion of enrolment in competing clinical trials.
Blinded data from the trial to date demonstrate that NNZ-2566 appears to be safe and well-tolerated and that the mortality rate to date is lower than expected.
Three biomarkers of brain injury are being collected during the first 72 hours following injury, beginning prior to administration of the study drug or placebo.
Each year, approximately 1.7 million people sustain a traumatic brain injury in the US alone.
Of these, 25% are classified as moderate to severe while the remaining 75% are classified as mild TBI or concussion. The potential global market for TBI and concussion is estimated at more than $4 billion.
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