NeuroVive reports topline results of phase III CIRCUS study in acute myocardial infarction


NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, reports
that the phase III CIRCUS study of CicloMulsion® in patients with a specific
type of heart attack known as ST-segment elevation acute myocardial infarction
(STEMI) did not meet its primary clinical endpoint in a topline analysis.
The topline analysis of the study data provides information on whether the
primary endpoint has been met or not. This result does not contain specific data
concerning the level of significance for either the composite endpoint or each
individual element of the composite endpoint. These will be revealed in the
subsequent detailed analysis. It is anticipated that the full results of the 12
-month data from the CIRCUS study will be made available in the third quarter.
Today’s topline result is expected to delay the commercialization of
CicloMulsion®.

“While the primary endpoint of the CIRCUS study has not been met, analysis of
the full 12-month data set will provide us with more information in regard to
which patients may have benefited from treatment with CicloMulsion®. These
results will help define next steps in the development and commercialization of
CicloMulsion®. The CIRCUS study is an independent, investigator-led study and we
will continue to collaborate with the lead investigator to further evaluate the
full 12-month study results as they become available,” commented NeuroVive’s CEO
Mikael Brönnegård.

"We are confident in the NeuroVive R&D pipeline and the potential of cyclophilin
inhibitors including CicloMulsion®. CicloMulsion® is one of several products and
projects in clinical and preclinical stages including the ongoing phase II
CiPRICS and CHIC studies. Our continuing clinical program coupled with a strong
research and development pipeline will support NeuroVive’s future growth,” he
added.

The primary endpoint is a composite of three separate outcomes: mortality,
hospitalization for heart failure and left-ventricular (LV) remodeling at 12
months post acute myocardial infarction. The primary objective of the study was
to determine whether CicloMulsion® can improve STEMI patient clinical outcomes
12 months after administration. CicloMulsion® or placebo was administered
directly prior to percutaneous coronary intervention (PCI), a common procedure
to reopen the coronary artery allowing the return of blood flow to the heart.
The study will continue for a further two years to investigate longer term
outcomes. CicloMulsion® is an investigational product and has not been approved
by regulatory agencies for the treatment of any medical condition.

The impact of the CIRCUS results on the future development of CicloMulsion® will
be communicated in the second half of 2015.
About ST-segment elevation myocardial infarction (STEMI)
Acute myocardial infarction (AMI), commonly known as heart attack, is caused by
blockage of a coronary artery obstructing blood flow to the tissue of the heart,
which results in cell damage or death (infarct) leading to reduced heart
function, heart failure and possible death. STEMI is a diagnostic classification
of more severe myocardial infarction in which the damage to the cardiac muscle,
caused by complete coronary artery blockage, is first detected by
electrocardiography (ECG).

About the CIRCUS study
The CIRCUS study (does Cyclosporine ImpRove Clinical oUtcome in ST elevation
myocardial infarction patients) is an ongoing phase III study assessing
CicloMulsion® in 975 patients undergoing PCI following STEMI to assess its
ability to protect cardiac tissue and improve clinical outcomes.

The study is a multicentre, randomized, placebo-controlled, double-blind,
investigator-initiated study. Patients received one intravenous dose of
CicloMulsion® (or placebo) prior to reperfusion therapy by PCI. The incidence of
the combined endpoint (mortality, hospitalization for heart failure, LV
remodeling) will be assessed at 12 months after treatment to determine whether
CicloMulsion® can improve the clinical outcome in STEMI patients. The study also
includes a number of secondary outcome measures designed to provide a more
detailed insight into CicloMulsion®'s ability to reduce a patient's level of
cardiac injury following PCI. There will also be further analyses at 36 months
after treatment to discover longer term effects of CicloMulsion®.

The trial is being led by Professor Michel Ovize, MD, PhD, of Hospices Civils de
Lyon (HCL), a leading expert in the field of cardiovascular medicine and it is
conducted by a clinical research organization (CRO) unit according to good
clinical practice (GCP) guidelines. The study has enrolled patients at centres
in France, Belgium and Spain.  The CIRCUS trial is an investigator-initiated
trial that is supported by a national PHRC program funded by the French Ministry
of Health (PHRC National 2010). Furthermore, it is supported by grants from
NeuroVive Pharmaceutical AB, Lund, Sweden, that also provides the study
treatment CicloMulsion® and matching placebo. Further details of this study can
be obtained at:
https:/www.clinicaltrials.gov/ct2/show/NCT01502774?term=CIRCUS&rank=1
About CicloMulsion®
NeuroVive’s drug candidate CicloMulsion®, a cremophor-free lipid emulsion
formulation of cyclosporine, is the first cyclophilin inhibitor in development
for the treatment of reperfusion injury. It is designed to prevent mitochondria
dysfunction in damaged cells and limit the numerous biochemical processes that
lead to secondary tissue damage. By protecting the mitochondria, CicloMulsion®
may safeguard continued energy production and ensure that the normal healing
process is able to carry out repairs and maintain cell functionality.
CicloMulsion®’s potential for treatment in connection with STEMI is currently
being evaluated in a clinical phase III study. CicloMulsion® is also being
evaluated in a phase II study for the prevention of renal injury during major
heart surgery with Skåne University Hospital in Lund, Sweden. CicloMulsion® is
an investigational product and has not been approved by regulatory agencies for
the treatment of any medical condition.
About NeuroVive
NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is
developing a portfolio of products to treat acute conditions through
mitochondrial protection. NeuroVive’s product CicloMulsion® is being evaluated
in an ongoing phase III study, CIRCUS, in myocardial infarction (STEMI) and a
phase II study, CiPRICS, in acute kidney injury. The NeuroSTAT® product is
currently being evaluated in a phase II study in traumatic brain injury.
NeuroVive’s research programs also include development of drug substances
against brain injury in stroke patients, and for cellular protection and energy
regulation in mitochondrial disease. NeuroVive’s shares are listed on NASDAQ
OMX, Stockholm, Sweden.
Disclaimer
This release may contain forward-looking statements that can be identified by
words such as “recommends,” “indicating,” “risk,” “recommended,” “believe,”
“could,” “commitment,” “will,” “implications,” “supports,” “thought,”
“designed,” “growing,” “continues,” or similar terms, or by express or implied
discussions regarding potential marketing approvals for CicloMulsion®, or
regarding potential future revenues from CicloMulsion®. You should not place
undue reliance on these statements. Such forward-looking statements are based on
the current beliefs and expectations of management regarding future events, and
are subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that
CicloMulsion® will be submitted or approved for sale in any market, or at any
particular time. Nor can there be any guarantee that CicloMulsion® will be
commercially successful in the future. In particular, management’s expectations
regarding CicloMulsion® could be affected by, among other things, the
uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally; the
company’s ability to obtain or maintain proprietary intellectual property
protection; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
manufacturing issues, and other risks and factors.
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:
Judith Moore, inVentiv Health, Tel: +44 (0)7932 053829 or
judith.moore@inventivhealth.com

It is also possible to arrange an interview with NeuroVive’s CEO Mikael
Brönnegård or COO 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.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 1 June 2015, at 8:30 a.m. CET.

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