NeuroVive's NeuroSTAT Project Receives USFDA Fast Track Designation

NeuroVive Pharmaceutical AB announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.

NeuroSTAT's FDA Fast Track designation makes NeuroVive eligible, for example, for more frequent meetings and written communication with the FDA, continuous feedback on each section of its New Drug Application, NDA (for sale and marketing in the US), as well as the possibility to have its NDA reviewed within a shorter timeframe. Fast Track designated drugs address unmet medical needs in serious conditions, and the process is designed to facilitate accelerated drug development and, ultimately, to get new drugs to patients faster.

NeuroSTAT protects and stabilizes mitochondria and is in development for treatment of moderate to severe traumatic brain injury. It focuses on secondary brain cell damage that occurs after a head trauma. The candidate drug has previously been evaluated in a European clinical Phase II trial focused on safety, where analyses of brain cell injury biomarkers showed signals of clinical effect. In addition, in a clinically relevant experimental model, NeuroSTAT significantly reduced the volume of brain injury by 35%. NeuroSTAT has orphan drug designation in both

Europe and the US.

"The Fast Track designation and the recently approved IND (Investigational New Drug) are tremendous successes for our candidate drug NeuroSTAT, and a significant external validation of its quality and potential to address a tremendous unmet medical need. This will strengthen our position in the field and give us an advantage in partnering discussions concerning our planned Phase II efficacy study", said NeuroVive's CEO

Erik Kinnman.

Traumatic brain injury (TBI) is caused by external force to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days after the acute trauma. The most common causes for TBI are trips and falls, traffic accidents and assault and battery

The aim for NeuroSTAT, which targets mitochondria, is to prevent the emergence of neurological and functional secondary brain damage after a traumatic injury, and thereby establish a therapy that will lead to increased survival, improved quality of life and preserved neurological function. NeuroSTAT has shown favorable properties in a Phase II clinical study that investigated safety, tolerability, pharmacokinetics, i.e. chemical metabolism, and passage to the brain, of two different doses of the active ingredient ciclosporin in patients with severe traumatic brain injury. Further, analyses of brain cell damage biomarkers in samples from the patients, gave a first signal of clinical effect. In addition, in advanced experimental TBI models at the

University of Pennsylvania (Penn), a 35% decrease in volume of brain injury was observed after NeuroSTAT treatment, as well as positive changes in brain energy metabolite levels and mitochondrial respiratory function, together with decreased generation of reactive oxygen species. NeuroSTAT has orphan drug designation in both Europe and the US.