Clinical Phase II study with NeuroSTAT® for traumatic brain injury passes safety evaluation

NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company,
announces that the independent safety committee has endorsed moving on to the
next dose level without any safety issues, following the treatment of 10 of 20
patients in the ongoing clinical Phase IIa study for traumatic brain injury with
the company’s drug candidate NeuroSTAT®. Consequently, the study will continue
as planned and move on to the next dosage group.
The ongoing CHIC study (Copenhagen Head Injury Ciclosporin Study) is an open
-label, non-comparative clinical Phase IIa study enrolling a total of 20
patients divided into two different dosage groups, where NeuroVive’s drug
candidate NeuroSTAT® is being evaluated for the treatment of patients with
traumatic brain injury. The study is being conducted at the Department of
Neurosurgery at Rigshospitalet, University of Copenhagen, with MD. Jesper Kelsen
as Principal Investigator.

The study’s first dosage group of 10 patients has now been treated with
NeuroSTAT® at the lower dose, and an interim analysis has been completed by an
independent safety committee in order to evaluate the treatment’s safety
profile. The analysis includes an evaluation of blood concentrations of
cyclosporin A (the active substance in NeuroSTAT®) and changes in intracranial
pressure and blood samples collected to analyze possible organ injury. According
to the analysis, the low-dose treatment is judged to be safe and the study will
now continue as planned with the higher dosage group including 10 additional
patients.

“We’ve now obtained important safety data on what we’ve designated to be the
lower dose of NeuroSTAT® for treating patients with traumatic brain injury. We
can now move on to include patients that will be treated with a higher dose.
This means that the study has reached an important milestone in the clinical
trial program of NeuroSTAT®,” commented NeuroVive’s CEO Mikael Brönnegård.

More information about the study
The primary objective of the CHIC study is to evaluate NeuroSTAT®’s safety and
pharmacokinetics in blood and cerebrospinal fluid of patients with severe
traumatic brain injury on the basis of two different dosage levels. Secondary
explorative measures will be completed to study NeuroSTAT®’s efficacy at the
mitochondrial level and to study how different biochemical processes are
affected by NeuroSTAT® following traumatic brain injury. In addition to interim
analysis, the safety profile of the treatment is evaluated continuously. More
information about the study has been published in the public database
ClinicalTrials.gov at: https://clinicaltrials.gov/ct2/show/NCT01825044

Current status of NeuroVive’s projects and drug candidates

[image]CicloMulsion®
NeuroVive’s product CicloMulsion® is the first cyclophilin inhibitor developed
for the treatment of reperfusion injury. The product’s potential in the
treatment of myocardial infarction is currently being evaluated in a clinical
phase III study. The last of a total of 972 patients was enrolled on 16 February
2014. The results of the study are due to be announced in the third quarter 2015
following the completion of the one-year follow-up of all patients and the
analysis of the study data. CicloMulsion® will also be evaluated in a number of
clinical phase II studies for the treatment of other acute cardiac and kidney
injury within the framework of the collaboration with Hospices Civils de Lyon
and Skånes University Hospital in Lund, Sweden.

NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with moderate
or severe traumatic brain injury. NeuroSTAT® is currently being evaluated in a
clinical phase IIa study at Copenhagen University Hospital. The study focuses on
safety and pharmacokinetics, and 10 of 20 planned patients have been enrolled so
far. A phase III study is currently being planned and designed. NeuroVive has
secured orphan drug designation for NeuroSTAT® for moderate and severe traumatic
brain injury in the US and EU, which implies market exclusivity for seven years
in the US and ten years in the EU, from the date NeuroVive obtains market
authorization.

NVP019
NVP019 is NeuroVive’s primary drug candidate in the company’s new portfolio of
potent cyclophilin inhibitors belonging to a family of molecules known as
Sangamides based on a new and unique polyketide engineering technology. NVP019
is being developed as the next generation cyclophilin inhibitor for the
treatment of reperfusion injury in myocardial infarct, but also for other acute
conditions where general protection of vital organs is central to the
progression of the disease. An intravenous formulation will be evaluated for
this purpose in collaboration with external parties such as Hospices Civils de
Lyon within the framework of the OPeRa program.

NVP018
NVP018 is an oral formulation based on the same active substance as NVP019. It
has been developed for treatment of Hepatitis B and was outlicensed to OnCore
Biopharma, Inc. (www.oncorebiopharma.com) in September 2014. OnCore Biopharma
has designated the drug candidate OCB030.

Other products
More information about all products developed by NeuroVive can be found at
http://www.neurovive.se/index.php/en/research-development/research-overview

About NeuroVive
NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is
developing a portfolio of products to treat acute cardiovascular and
neurological conditions through mitochondrial protection. These medical
conditions are characterized by a pressing medical need and have no approved
pharmaceutical treatment options at present. NeuroVive’s products CicloMulsion®
(myocardial infarct) and NeuroSTAT® (traumatic brain injury) are currently being
evaluated in phase III and phase II studies, respectively. NeuroVive’s research
programs also include development of treatments against brain injury in stroke
patients, and drug substances for cellular protection and treatment of
mitochondrial disorders causing energy deficiency. NeuroVive’s shares are listed
on NASDAQ OMX, Stockholm, Sweden.

For Investor Relations and media questions, please contact:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46 275 62 21 or ir@neurovive.se
It is also possible to arrange an interview with NeuroVive’s CEO Mikael
Brönnegård or COO Jan Nilsson at the above contact.

NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden, Tel: +46 (0)46 275 62 20 (switchboard),
Fax: +46 (0)46 888 83 48
info@neurovive.se, www.neurovive.se

NeuroVive Pharmaceutical AB (publ) is required to publish the information in
this news release under The Swedish Securities Market Act. The information was
submitted for publication on 21 April 2015, at 9.45 a.m. CET.
NeuroVive Pharmaceutical AB (publ) - the mitochondrial medicine company. The
company is listed on NASDAQ OMX Stockholm, Small Cap, under the ticker symbol
NVP. The share is also traded on the OTC market in the US. NeuroVive
Pharmaceutical (OTC: NEVPF) trades on the OTC Grey Market. Investors can find
Real-Time quotes and market information for the company
at www.otcmarkets.com/stock/NEVPF/quote (http://htt://www.otcmarkets.com/stock/N
E 
VPF/quot)