NeuroVive reports favourable safety evaluation in Phase II acute kidney injury study

Lund, Sweden, 19 November 2015 – NeuroVive Pharmaceutical AB (publ), the
mitochondrial medicine company, announces that the independent safety committee
has endorsed the continuation of the on-going Phase II CiPRICS (Ciclosporin to
Protect Renal function In Cardiac Surgery) study following the enrolment of the
first 50 patients in the study.
The assessment is conducted in order to evaluate the treatment’s safety profile.
On the basis of satisfactory safety findings, the study will continue as planned
with the goal to enrol 150 patients and complete the study in the second half of
2016. The CiPRICS study has enrolled about 60 patients to date and is
progressing as planned.

The CiPRICS study is an investigator led Phase II Double Blind Randomized
Placebo Controlled Study evaluating ciclosporin (CicloMulsion®) for the
prevention of acute kidney injury (AKI) in patients undergoing major surgery.
The study is a proof-of-concept study for AKI and further studies will be
required in order to advance the NeuroVive clinical development program in this
area. Henrik Bjursten, MD, PhD is the Principal Investigator of the study, which
is being conducted at the Department of Cardiothoracic Surgery at
Skåne University Hospital.

“This independent assessment shows that there seems to be no safety issues with
ciclosporin (CicloMulsion®) in this patient population and allows us to continue
our investigation in acute kidney injury which is of high interest to our team
in Lund,” Dr. Henrik Bjursten commented.

“This is an important milestone for our clinical development programme in acute
kidney injury and provides NeuroVive with confidence to further progress our
research in this core therapy area. We will continue to work closely with the
study investigators to move forward from here, complete the study and have the
results available in the second half of 2016," Jan Nilsson, NeuroVive interim
Chief Executive Officer commented.

Acute kidney injury (AKI) may occur after major surgeries, such as coronary
artery bypass surgery (CABG), which is performed annually in over 400,000 people
worldwide. There are currently no approved pharmacological AKI treatment options
available and patients with AKI during CABG surgery risk developing end stage
renal disease, which is a serious and costly consequence requiring dialysis in a
number of cases. There is growing interest both scientifically and commercially
in AKI based on the need to provide new treatment options for these patients.
Earlier this year, Pfizer acquired a minority interest in A-M Pharma for their
AKI investigational compound, which highlights the growing interest in this
therapeutic area.

About NeuroVive
NeuroVive Pharmaceutical AB (publ) is a leading mitochondrial medicine company
committed to the discovery and development of highly targeted candidates that
preserve mitochondrial integrity and function in areas of therapeutic need.
NeuroVive’s business approach is driven by value-adding partnerships with
leading mitochondrial research institutions and commercial partners across the
globe.

NeuroVive’s portfolio consists of two projects in acute kidney injury (AKI) and
traumatic brain injury (TBI) with candidates in clinical and preclinical
development and two drug discovery platforms. The NeuroSTAT® product is
currently being evaluated in a Phase II study in traumatic brain injury.
CicloMulsion® is being evaluated in an on-going Phase II study, CiPRICS, in
acute kidney injury during major surgery. NeuroVive’s shares are listed on
NASDAQ OMX, Stockholm, Sweden.

More information about the study
The CiPRICS study (Ciclosporin to Protect Renal function In Cardiac Surgery) is
a double-blind, randomized and placebo-controlled clinical Phase II study
including a total of 150 patients. The patients are being treated with
CicloMulsion® or placebo in connection with coronary artery bypass surgery
(CABG) at the Department of Cardiothoracic Surgery at Skåne University Hospital
in Lund, Sweden. The study is investigator-initiated and is conducted by Skåne
University Hospital with support from NeuroVive, which is providing the
investigational product, CicloMulsion®. In addition to the predefined safety
analyses, 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/NCT02397213

For investor relations and media questions in Sweden, please contact:
Johannes Nebel, Laika Consulting, Tel: +46 (0)735 81 71 68 or ir@neurovive.se

For media questions outside Sweden, please contact:
Gemma White, inVentiv Health, Tel: +44 (0)77 13 88 9992 or
gemma.white@inventivhealth.com
It is also possible to arrange an interview with NeuroVive’s interim CEO Jan
Nilsson at the above contacts.

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.com

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 the 19th November 2015, at 08.30 CET.