Neuren Pharmaceuticals (ASX:NEU) has received approval from the U.S. Army to commence enrolling subjects in its Phase 2 clinical trial for its NNZ-2566 drug treating concussion.
Concussions make up most cases of traumatic brain injury and there is currently no approved drug therapy available for acute concussion.
The trial is being conducted with the U.S. Army’s 82nd Airborne Division at Fort Bragg in North Carolina, as a continuation of the collaboration between Neuren and the US Army on the development of potential therapies for traumatic brain injury.
NNZ-2566
NNZ-2566 has the potential to address cellular and molecular changes in the brain that are known to be caused by concussion.
In animal models, it has been shown to inhibit neuroinflammation, normalize microglial function, restore synaptic signalling and increase IGF-1 expression in the brain.
The profile of the military population for the trial is similar to the profile of athletes in the relevant sports, which are also a key target market.
Top line results from the double-blind, placebo-controlled trial will be available in the second half of 2015.
Approximately 132 subjects with concussion will be enrolled and receive treatment with either NNZ-2566 or placebo for seven days post-injury.
Two dose levels of orally administered NNZ-2566 are being tested. A number of measures assessing physical and emotional symptoms and cognitive function will be analysed, together with safety and tolerability measures.
Neuren is fully funded through to completion of Phase 2 trials in 4 different indications with trials in progress for Rett Syndrome, Fragile X Syndrome, Concussion and Traumatic Brain Injury.
It has $22 million in cash reserves.
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