In response to an earlier query, the US Department of Defense’s TBI research funding is certainly not limited to Neuren’s Phase 2 trials of NNZ-2566 in both mild and moderate to severe TBI.
US Defense grants to Neuren to date for NNZ-2566 in TBI have totaled approx. $25 million. Total U.S. Department of Defense spending on TBI research to date has exceeded $700 million and has been spread over more than 500 research projects, although many of these have been non-pharmacological projects, for example, in diagnosis or rehabilitation therapies.
The U.S. Army Medical Research and Materiel Command (USAMRMC) recently published the findings of a TBI Pharmacology Workgroup which it had tasked with assessing the current state of the science and ongoing research in TBI and with identifying research gaps to inform future development of research priorities for TBI research. Its report, which was published in January’s edition of the Journal of Neurotrauma, provides a valuable insight into the current state of play in TBI clinical trial research. (1)
The report includes a table (Table 2) of pharmacotherapies which are currently undergoing Phase 2 or Phase 3 clinical evaluation and for which results are pending. There are dozens of drugs listed. NNZ-2566 is included in the list of therapies for acute stage severe and acute stage moderate TBI. It appears to be the only novel drug listed, the others being a range of established drugs for diverse indications.
One of these is Glyburide, a drug approved for the treatment of Type 2 diabetes, which is thought to potentially impact cerebral edema and secondary hemorrhage. It has been in Phase 2 trials since late 2011 and study completion is expected in September this year. (2) The Glyburide trial is in approximately 100 patients with mild, moderate and severe TBI. Sponsor of the trial is a small US-based pharma, Remedy Pharmaceuticals, and funding has been provided by the US Department of Defense, which has described the drug as “promising” (1, 3)
The US Department of Veteran Affairs is also currently sponsoring clinical trials in other potential TBI therapies. A proof-of-concept 100 patient trial of the (statin) simvastatin in mild TBI is due for completion in 2018. A Phase 3 trial of the rivastigmine patch (Alzheimer’s) for cognitive impairment following TBI is due for completion in 2017. There are still more trials of other repurposed drugs which are also US government funded in some way.
It’s worth noting that the report also identifies the finding of therapies aimed at promoting neurorepair, neuroregeneration, and neuroprotection as one of its most critical research priority areas, because of the potential of such therapies to be effective over a prolonged period after injury. Areas which are identified as having critical research need receive assistance and funding priority from the US government.
In summary, the TBI Pharmacology report shows that there are many “competitor” clinical trials in TBI to those of Neuren and most of these US-based trials have received some form of US government assistance. The fact that NNZ-2566 addresses an area of critical research need suggests to me that if NNZ-2566 is successful in either of its TBI Phase 2 trials, further US Department of Defense funding for Phase 3 trials would seem highly likely.
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