NeuroVive signs collaboration agreement with University of Florida for TBI biomarker development

Lund, Sweden, 31 October 2017 - NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) today announced that the company has signed a collaboration agreement with Kevin K.W. Wang, Ph.D., of the University of Florida to conduct biomarker research for NeuroVive’s traumatic brain injury (TBI) program. The research is aimed at developing alternative endpoints for the company’s clinical TBI program by analysing patient samples from the previously completed CHIC study.

The research will evaluate the use of biofluid-based biomarkers in TBI drug development, which is increasingly recognized as being of utmost importance for diagnosis, prognosis and therapy evaluation. The research will be conducted at a laboratory at the University of Florida’s McKnight Brain Institute focused on neurotrauma, neuroproteomics and biomarkers research headed by Wang.

“The collaboration with Dr. Wang and his research team at the University of Florida will greatly aid us in the continued development of our TBI candidate drug NeuroSTAT. NeuroSTAT has displayed promising results in our recent experimental study at the University of Pennsylvania and in the clinical CHIC study. The results from this biomarker analysis will be very useful in further optimizing our upcoming phase II efficacy study,” said Magnus Hansson, M.D., Ph.D., Chief Medical Officer, NeuroVive.

Wang is an expert in biomarker research for TBI and part of several multicenter collaborative efforts to improve knowledge and clinical trial design in TBI, including the U.S.-based efforts TRACK-TBI (Transforming Research and Clinical Knowledge in Traumatic Brain Injury) and TED (TBI Endpoints Development), as well as the European CENTER-TBI initiative.

“We have a team of very talented biomarker researchers here at our research laboratory at University of Florida who investigate TBI-related biomarkers that can serve to improve diagnosis, strengthen short- and long-term patient care, and assist clinical trials for new therapy development, which is the goal of our collaboration with NeuroVive”, said Wang, who is also an Associate Professor of Emergency Medicine, Psychiatry, Neuroscience in the UF College of Medicine and a member of the McKnight Brain Institute.

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on 31 October 2017. 

For more information please contact:

Daniel Schale, Director of Communications, NeuroVive

+46 (0)46-275 62 21, ir@neurovive.com

NeuroVive Pharmaceutical AB (publ)

Medicon Village, SE-223 81 Lund, Sweden

Tel: +46 (0)46 275 62 20 (switchboard)

info@neurovive.com, www.neurovive.com

About McKnight Brain Institute

The Evelyn F. and William L. McKnight Brain Institute of the University of Florida is a premier research and educational center devoted to the study of neurodegenerative diseases, brain injury, spinal cord injury, brain tumors, addiction and age-related memory loss. The MBI is among America’s most comprehensive and technologically advanced centers focused on discovering how the normal brain operates and how the brain can be repaired following injury, disease or aging.

About 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 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. In the US, some 2.2 million people are affected annually, causing more than 50,000 deaths and 280,000 hospitalizations. The direct and indirect costs associated with TBI are an estimated USD 60 billion, and a large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of support (www.nih.gov). The aim is that better preventive therapies for secondary brain damage, such as NeuroSTAT, will lead to higher survival rates, and significantly improve quality of life and neurological function of patients post-TBI.

About NeuroVive

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).

About Us

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 also consists of projects for genetic mitochondrial disorders, cancer and NASH. The company advances drugs for rare diseases through clinical development into the market. For projects for common indications the goal is out-licensing in the preclinical phase. A subset of compounds under NeuroVive’s NVP015 program has been licenced to Fortify Therapeutics, a BridgeBio company, for local treatment development of Leber’s Hereditary Optic Neuropathy (LHON). NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF). www.neurovive.com

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