Cardiorentis initiates first-ever acute heart failure Phase III clinical trial designed to assess early treatment on cardiovascular mortality and symptoms

Zug, Switzerland (ots/PRNewswire) -

Cardiorentis has initiated the first-ever acute heart failure
(AHF) Phase III trial to be specifically designed to assess the
effect of early treatment on cardiovascular mortality. TRUE-AHF
(TRial of Ularitide's Efficacy and safety in patients with Acute
Heart Failure) aims to show that early treatment with intravenous
(IV) ularitide may reduce AHF symptoms in the short-term and
cardiovascular mortality in the long-term. Health authorities have
agreed with the designation of cardiovascular mortality as a primary
efficacy endpoint, and patient enrolment is already underway in the
US and Europe.

Heart failure is a significant public healthcare concern, with an
overall population prevalence of approximately one to three per cent,
rising to approximately 10 per cent in the very elderly. AHF is one
of the most common reasons for unscheduled hospitalisation of people
over the age of 65 years.[i] AHF patients are at a markedly increased
risk of rehospitalisation within three months of their first episode
and experience mortality rates five-times greater than that of
patients following a heart attack.[ii],[iii]

"The TRUE-AHF is a landmark study. We believe that early
decompression of the dilated heart can reduce myocardial injury in
patients with acutely decompensated heart failure," commented Milton
Packer, M.D., chair of the trial, Professor and Chair, Department of
Clinical Sciences, University of Texas Southwestern Medical Center.
He continued, "If decompression produced by a 48-hour infusion of
ularitide can prevent significant myocardial damage during this
vulnerable period, then we are likely to see a reduction in
cardiovascular mortality over the following months and years."

TRUE-AHF is designed to build on the growing body of evidence that
suggests patients suffering from AHF should be treated as early as
possible. Heart failure experts, cardiologists and emergency
physicians are working hand-in-hand to ensure an early enrolment of
patients into the trial (within the first hours after presentation to
the hospital). The trial is evaluating the following endpoints:

- A composite score that assesses the symptoms and clinical course of
patients during the 48-hour infusion of ularitide.
- Cardiovascular mortality following randomisation for the entire duration of
the trial

"We have been in close discussions with the health authorities to
achieve the most robust study design for TRUE-AHF. We wanted the
study design to reflect our belief that ularitide could provide
symptom improvement and a reduction in cardiovascular mortality,
which are both crucial measures for new therapies being investigated
for the treatment of AHF. Following promising results in previous
clinical trials SIRIUS I and II, we are confident ularitide will
provide clinicians with a much-needed addition to their AHF treatment
armamentarium," said Elmar Schnee, CEO Chairman at Cardiorentis Ltd.
"We are also encouraged that such a highly regarded group of
cardiologists and emergency physicians are working in partnership
with us on the clinical programme," he added.

Approximately 190 centres across the US, Europe, Canada and Latin
America will be involved in the TRUE-AHF trial, and approximately
2,152 patients with AHF will be randomised to receive placebo or
ularitide for 48 hours in addition to standard care.

Notes to editors

About Ularitide

Ularitide is an advanced natriuretic peptide in Phase III
development as an intravenous (IV) infusion treatment for acute heart
failure (AHF). Ularitide is the chemically synthesized form of
urodilatin - a human, natriuretic peptide that is produced in the
kidneys and induces excretion of sodium into the urine (natriuresis)
and increased urine production (diuresis) to regulate fluid balance
and sodium haemostasis. Ularitide induces natriuresis and diuresis by
binding to specific natriuretic peptide receptors (NPR-A, NPR-B and
other natriuretic peptide receptors), thereby increasing
intracellular cyclic guanosine monophosphate (cGMP) helping to relax
smooth muscle tissues, leading to vasodilation and increased blood
flow.

About AHF

Heart failure is a growing problem worldwide. More than 23 million
people around the world are affected.[iv],[v] AHF can be defined as
the sudden or gradual onset of the signs or symptoms of heart failure
resulting in a need for urgent therapy or hospitalisation.[vi ] It is
a life-threatening condition which requires immediate medical
attention. Signs and symptoms of AHF include extreme fatigue and
shortness of breath, worsening kidney function, severe swelling,
sudden weight gain and a distended jugular vein along the side of the
neck.

About Cardiorentis Ltd.

Cardiorentis is a private biopharmaceutical company headquartered
in Zug, Switzerland. Cardiorentis is committed to bringing novel
therapies to the treatment of heart failure and related
cardiovascular diseases. The company's disease-based technology
platform integrates expertise in protein biology to identify novel
targets and rationally design small molecule compounds and peptides
for markets with unmet medical needs. For more information, visit
http://www.cardiorentis.com

References

i. Adams KF, Lindenfeld J, Arnold JMO, et al. Executive summary:
HFSA 2006 comprehensive heart failure practice guideline. J Card Fail
2006;12:10-38.

ii. Acute decompensated heart failure national registry. 2007;
Available at: URL: http://www.adhereregistry.com/

iii. Gheorghiade M, Zannad F, Sopko G, et al. Acute heart failure
syndromes: current state and framework for future research.
Circulation 2005 December 20;112(25):3958-3968.

iv. Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related
hospitalization in the U.S.,1979 to 2004. J Am Coll Cardiol
2008;52(6):428-34.

v. McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical
epidemiology of heart failure: public and private health burden. Eur
Heart J 1998; 19 Suppl P:P9. [http://www.uptodate.com/contents/epidem
iology-and-causes-of-heart-failure/abstract/8 ]

vi. Jessup. M, et al. 2009 Focused Update: ACCF/AHA Guidelines for
the Diagnosis and Management of Heart Failure in Adults. Circulation.
2009 Apr 14;119(14):1977-2016.

ots Originaltext: Cardiorentis
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