Drug joint venture starts to bear fruit for Neuren

David Clarke says commercial production of Neuren's brain injury drug is five years away. Picture / Mark Mitchell

Auckland biotechnology company Neuren Pharmaceuticals' co-operation with the US Army is beginning to bear fruit, with the pair applying for a joint patent for Neuren's brain injury drug.

Australian-listed Neuren's chief executive, David Clarke, said commercial production of the drug - known as NNZ-2566 - was at least four or five years away.

But with about two million people worldwide suffering a traumatic brain injury each year, the market potential of an effective drug to treat those injuries was estimated at US$1 billion ($1.6 billion).

The drug is for the prevention of non-convulsive seizures in the treatment of brain injury and is the result of research done with the US Army under a co-operative agreement signed in March last year.

During a non-convulsive seizure, the patient displays no outward physical signs but the brain damage suffered can be just as severe.

Frank Tortella, chief of the department of applied neurobiology at the US Army's Walter Reed Army Institute of Research, said results with NNZ-2566 reinforced the value of using drugs to treat non-convulsive seizures.

"Development of a safe, effective treatment for brain trauma that can be delivered after injury by those on the scene, including combat medics or civilian emergency medical personnel, without the need for extensive and time-consuming diagnostic workups is an extremely high priority for our military and civilian medical communities," he said.

The NNZ-2566 molecule, which was developed under the leadership of New Zealand scientist Professor Peter Gluckman, has recently begun a phase one trial for safety and tolerability.

Experiments conducted by the Walter Reed Institute in animals for non-convulsive seizures using NNZ-2566 reduced the incidence of seizure by 35 per cent and reduced the average duration of a seizure by 39 per cent.

Non-convulsive seizures often occur soon after brain injury and are important in predicting the eventual outcome for the patient.

Neuren said the benefit of NNZ-2566 in preventing these seizures built on the "already significant" evidence of the drug's effectiveness.

Clarke said these findings together with earlier positive results gave encouragement to progress the drug into phase two human clinical trials as soon as was practical.

The US Army is developing the phase two protocols with Neuren with the trials expected to start next year, dependent on regulatory approval of phase one results.

Neuren said the beneficial effects of NNZ-2566 in reducing seizures also strongly suggested the drug might have similar benefits in traumatic brain injury and stroke patients.

The potential for treating ischemic and haemorrhagic stroke could open the drug to an additional three million patients with an estimated market value of US$4 billion worldwide.

Clarke said development of a stroke application would need to be done under a separate agreement.