NeuroVive has previously communicated the top line results from the experimental evaluation of NeuroSTAT performed in collaboration with Penn. The most significant finding was a 35% reduction of brain injury volume when NeuroSTAT was given as neuroprotective treatment after the acute TBI trauma. The comprehensive study results have now been published in the Journal of Neurotrauma, the well-respected official journal of the National Neurotrauma Society and the International Neurotrauma Society.
A pre-clinical trial was conducted in an advanced model of TBI examining both pharmacokinetics and efficacy. The study was carried out in a fashion that resembles a clinical trial and was fully blinded and placebo-controlled. In the publication, it is demonstrated that NeuroSTAT enters the brain and that the drug significantly reduced the volume of brain injury by 35% and also improved energy metabolism in the adjacent brain tissue. The experimental model used is considered to be highly clinically relevant. The outcome measures in the experimental model were evaluated by magnetic resonance scans, which is directly translatable to clinical trials. Magnetic resonance imaging is planned to be the primary outcome measurement in NeuroVive’s planned phase II efficacy trial.
The paper by Michael Karlsson and colleagues has the title “Neuroprotective effects of cyclosporine in a porcine pre-clinical trial of focal traumatic brain injury” and can be accessed at the following link:
“The data from this fruitful collaboration with Penn has already generated significant interest when presented at scientific congresses, and now the whole scientific community will be able to access the study results of NeuroSTAT. A significant aspect of the data is that the protective capabilities are seen in outcome metrics that can directly be tested in our further clinical trials. This will facilitate the progression of the NeuroSTAT clinical program and our goal to deliver a medicine that improves the outcome of patients following TBI,” commented Magnus Hansson, Chief Medical Officer and VP of Preclinical and Clinical Development at NeuroVive.
The information was submitted for publication, through the agency of the contact person set out below, at 09:00 a.m. CEST on 28 June 2018.
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About traumatic brain injury (TBI)
Traumatic brain injury (TBI) is caused by external violence to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days after the acute trauma, which in many cases has a significantly negative effect on the overall injury. At present, there are no approved treatments for the prevention of these secondary injuries. With more than 50 million new cases occurring each year, TBI is estimated to cost the global economy nearly 400 billion dollars annually in direct and indirect healthcare costs.1) A large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of support. The aim is that preventive therapies for secondary brain damage, such as NeuroSTAT, will lead to higher survival rates, and significantly improve quality of life and preserved neurological function of patients after TBI.
1) Maas A et al. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. The Lancet Neurology. 2017 Nov; 16(12):987.
NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project in clinical phase I (KL1333) for genetic mitochondrial diseases. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. The company’s strategy is to advance drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).