Neuren to start Phase 2 trial

THE ROADHOUSE PHARMACY: Neuren Pharmaceuticals (ASX: NEU) has received approval from the Institutional Review Board at Womack Army Medical Centre to start its Phase 2 clinical trial of NNZ-2566 in concussion (also referred to as mild traumatic brain injury).

The double-blind, placebo-controlled trial will be conducted with the US 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.

Neuren said that the trial preparations are well advanced and enrolment of subjects will commence as soon as approval is received from the Human Research Protection Office (HRPO) of the US Army Medical Research and Materiel Command.

The trial will involve approximately 132 subjects with mild traumatic brain injury, who 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.

Neuren explained that a number of measures assessing physical and emotional symptoms and cognitive function will be analysed, together with safety and tolerability measures and the company expects that top-line results from the trial will be available in the second half of 2015.

There is currently no approved drug therapy available for acute concussion.

Neuren indicated its trial is a world-first commercial sponsored clinical trial of a potential new medicine in this therapeutic area.

Test conducted using animal models have demonstrated NNZ-2566 to inhibit neuroinflammation, normalize microglial function, restore synaptic signalling and increase IGF-1 expression in the brain.

Neuren considers these effects have the potential to address cellular and molecular changes in the brain caused by concussion.

“Given the known properties of NNZ-2566, we are hopeful that this important trial is able to demonstrate the potential for NNZ-2566 to help mitigate the serious health and economic ramifications of concussions, which are now being recognised in civilian, sporting and military communities around the world,” Neuren Pharmaceuticals executive chairman Richard Treagus said in the company’s announcement to the Australian Securities Exchange.