SOURCE: Congenia S.R.L.

August 27, 2013 02:00 ET

Congenia S.R.L.: Enrollment of First Healthy Volunteer in Phase 1

MILAN, ITALY--(Marketwired - Aug 27, 2013) -

Congenia Announces Enrollment of First Healthy Volunteer in Phase 1
Clinical Trial of GNX-5086

Milan, August 27th 2013 - Congenia, a clinical stage biopharmaceutical
company focused on developing inhibitors of the mitochondrial
permeability transition pore (mPTP), announces that on August 15th
2013, the initiation of healthy volunteer enrollment in a Phase 1
clinical trial evaluating the safety and tolerability of GNX-5086.
GNX-5086 is a potent small molecule inhibitor of the mPTP, a novel
target involved in modulating stress induced cell death. GNX-5086 is
being developed to treat cardiac reperfusion injury (RI) that
contributes significantly to the morbidity and mortality subsequent
tomyocardial infarction (MI). There are currently no therapies approved
for myocardial RI.

The randomized, double-blind, placebo-controlled Phase 1 study in
healthy subjects is designed to evaluate the safety, tolerability and
pharmacokinetics of single ascending doses of GNX-5086. The study is
expected to enroll 33 healthy volunteers. GNX-5086 is being developed
for intravenous administration to infarcted patients just prior to
percutaneous coronary intervention (PCI).

The clinical trial application (CTA) to initiate the Phase 1 study of
GNX-5086 was filed on July 4th 2013 in the Netherlands and received
approval by the local regulatory authorities on July 24th.

About cardiac reperfusion injury and GNX-5086

Myocardial infarction (MI) results from the partial interruption of
blood supply to a part of the heart muscle. The resulting ischemia and
ensuing oxygen shortage, if left untreated can cause damage or death of
heart muscle tissue. As a result, the patient's heart will be
permanently damaged. Acute MI is a major cause of death and disability
worldwide. In patients with AMI, the treatment of choice for limiting
infarction size is timely and effective myocardial reperfusion using
either thrombolytic therapy or primary percutaneous coronary
intervention (PCI). However, the process of reperfusion can itself
induce cardiomyocyte death, known as myocardial reperfusion injury
(RI), that can be responsible for one-third or more of cell death and
for which there is still no effective therapy. Inhibition of the mPTP
is proposed as a cardioprotective strategy for the limitation of
infarct size in patients undergoing PCI. GNX-5086 is Congenia's most
advanced compound and was selected as lead compound through a
longstanding preclinical collaboration with the Drug Discovery Program
of the European Institute of Oncology (DDP-IEO). GNX-5086 is a potent
mPTP inhibitor able to increase the capacity of isolated mitochondria
to retain calcium and thus protect the mitochondria from calcium
overload in stress situations. In vivo studies using a rabbit model of
acute myocardial infarction clearly demonstrate the effectiveness of
GNX-5086 in attenuating RI and reducing infarct size when administered
just prior to heart reperfusion.

About Congenia

Congenia S.r.l. is a biopharmaceutical company based in Milan (Italy)
fully owned by Genextra SpA and is one of the first companies focused
on targeting specifically the mitochondrial permeability transition
pore (mPTP). Originally spinned out from the University of Milan and
the European Institute of Oncology was then acquired by Genextra SpA.
Congenia's main focus is on inhibiting the opening of the mPTP, a
protein channel with multiple macromolecular components associated with
oxidative stress-induced cell death. Mitochondrial permeability
transition is an increase in the permeability of the mitochondrial
membranes to molecules of less than 1500 Daltons in molecular weight
and results as a consequence of the opening of the mPTPs. Oxidative
damage and calcium dysregulation are common features of many"age-related"
diseases and therefore opening of the mPTP in response to
these phenomena has been suggested to be involved in the pathogenesis
of several diseases, including myocardial infarction, stroke,
neurodegenerative, cardiovascular, and metabolic diseases. Congenia
aims at clinically validating its mPTP is in RI as well as other

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