LUND, Sweden, Oct. 4, 2018 NeuroVive Pharmaceutical AB
(Nasdaq Stockholm: NVP, OTCQX: NEVPF) today announced the successful completion of biomarker analyses of samples from
its clinical study in severe traumatic brain injury patients (the CHIC study) using the company's investigational compound
NeuroSTAT. The results provide an early signal of efficacy derived from time-based changes in biomarker levels that correlate
with NeuroSTAT drug administration.
Patient samples from the previously completed CHIC study have been analyzed in a research collaboration with Kevin K.W. Wang, Ph.D., at the University of Florida. The aim of the collaboration
is to develop innovative endpoints for NeuroVive's clinical traumatic brain injury (TBI) program.
The GFAP, UCH-L1, NF-L and Tau biomarkers, which reflect different aspects of the ongoing brain cell damage following TBI,
were measured in repeated samples of cerebrospinal fluid from the severe trauma patients in NeuroVive's CHIC study. The results
show a time-based change in biomarker levels correlating with NeuroSTAT drug administration for all four biomarkers. These
biomarkers are being developed with the aim of improving diagnosis, enhancing short and long-term patient care and assisting
clinical trials developing new treatments for TBI.
"This early efficacy signal indicates that NeuroSTAT suppresses the secondary brain injury cascade and clearly supports our
continued development of NeuroSTAT for TBI. The results from this fruitful collaboration are very promising in relation to our
efforts to optimize efficacy measurement in TBI drug development and bring the much-needed treatment options to these patients,"
commented Magnus Hansson, Chief Medical Officer and VP of Preclinical and Clinical Development at
NeuroVive.
The company plans to use these innovative biomarkers as outcome measures together with other new endpoints to establish proof
of concept for NeuroSTAT in its next larger randomized, placebo-controlled phase II efficacy study, planned to start in 2019.
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 below, at
08:30 a.m. CEST on 4 October 2018.
For more information please contact:
Catharina Johansson
CFO, IR & Communications
+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 biomarkers in TBI drug development
The use of biofluid-based biomarkers in TBI drug development is increasingly recognized as being of utmost importance for
diagnosis, prognosis and therapy evaluation. GFAP (Glial fibrillary acidic protein), UCH-L1 (Ubiquitin carboxy-terminal hydrolase
L1), NF-L (Neurofilament Light) and Tau are proteins found in different cells and cellular compartments of the brain. They are
released following injuries to astrocytes, neurons and axons, respectively, and their levels in blood and cerebrospinal fluid
have been correlated to the severity of several different brain diseases. The FDA has recently approved a GFAP and UCH-L1-based
blood test for diagnosis of mild TBI. 1)
1) https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm
About traumatic brain injury (TBI)
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. 2) 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. 3) A
large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of
support.
2) www.internetmedicin.se/page.aspx?id=1178
3) Maas A et al. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. The Lancet
Neurology. 2017 Nov; 16(12):987.
About the Phase IIa clinical study CHIC and NeuroSTAT
The phase II CHIC (Copenhagen Head Injury Ciclosporin) study was an open label study. The primary objective with the study was
to establish safety and to characterize the pharmacokinetic profile of two dosing regimens of NeuroSTAT in severe Traumatic Brain
Injury (TBI) patients. In addition, exploratory measurements to evaluate the efficacy of NeuroSTAT at mitochondrial level, and
studies on how NeuroSTAT affects various biochemical processes after a brain injury, were conducted. Principal Investigator for
the study is Jesper Kelsen, MD, PhD, Specialist in Neurosurgery, Department of Neurosurgery,
Rigshospitalet, Copenhagen University Hospital.
NeuroSTAT has been shown to reduce the volume of brain injury by 35% in a pre-clinical trial using an advanced experimental
model of TBI. 4) NeuroSTAT has orphan drug designation in both Europe and the US. NeuroVive has
also partnered with TRACK-TBI, a network of leading TBI researchers in the US with the mission to improve clinical trials in
TBI.
4) Karlsson et al. J Neurotrauma. 2018: https://www.liebertpub.com/doi/10.1089/neu.2018.5706
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 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).
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SOURCE NeuroVive Pharmaceutical