CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cardurion Pharmaceuticals, a biotechnology company focused on the development of novel, next-generation therapeutics for the treatment of cardiovascular diseases, today announced preclinical results from its study of CRD-733, the company’s novel Phosphodiesterase-9 enzyme (PDE-9) inhibitor, in a poster presentation at the American Heart Association (AHA) Scientific Sessions in Chicago. In a study of mice with left ventricular hypertrophy (LVH) in a standard preclinical heart failure model, mice treated with CRD-733 were protected from LVH and showed improvement in several other markers of heart failure.
“These data provide strong evidence for the potential therapeutic benefit of PDE9 inhibition in a preclinical model of heart failure,” said Daniel Bloomfield, M.D., chief executive officer at Cardurion Pharmaceuticals. “Based on these data, and the established safety and tolerability of CRD-733 in humans, we are excited to announce initiation of the first clinical trial of CRD-733 in patients with heart failure.”
As a result of Cardurion Pharmaceuticals’ preclinical data, the recent successful Phase 1 study in normal subjects, and the safety and tolerability of CRD-733 in more than 250 subjects to date, the company has now initiated its Phase 1b study in heart failure. The randomized, double-blind study is evaluating CRD-733 in patients with heart failure in the U.S. and Europe. The trial will include 44 patients in each sub-population of heart failure, heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). Results are expected in 2019.
About CRD-733
CRD-733 is a Phosphodiesterase-9 enzyme
(PDE-9) inhibitor. PDE-9 activity is abnormally elevated in heart
failure which can impede activation of the heart’s normal responses to
stress and make the heart more vulnerable to damage. In preclinical
models of heart failure, inhibiting PDE-9 with CRD-733 restores these
heart-protective mechanisms and has been shown to prevent and reverse
heart muscle malfunction brought on by abnormal stress. Cardurion
Pharmaceuticals obtained an exclusive, worldwide, royalty-bearing
license from Astellas to research, develop, manufacture and
commercialize CRD-733 for the diagnosis, prevention, and treatment of
cardiovascular-related indications in humans.
About Heart Failure
Heart failure is marked by progressive
weakening or stiffening of the heart muscle and the organ’s gradual loss
of blood-pumping ability. Although symptoms can be managed, this is a
chronic condition with no cure. With more than 26 million people with
heart failure worldwide1 and 6.5 million people with heart
failure in the United States2, heart failure is the most
important remaining unmet need in cardiovascular disease. In the United
States, heart failure accounts for more than 1 million hospital
admissions2 and costs approximately $30 billion dollars each
year to treat3. Not only are these costs expected to rise to
almost $70 billion by 20303, the incidence of heart failure
is projected to rise 46 percent – resulting in more than 8 million
people with heart failure in the United States4. There are
two forms of heart failure: heart failure with reduced ejection fraction
(HFrEF) and heart failure with preserved ejection fraction (HFpEF).
HFrEF, formerly known as systolic heart failure, is characterized by a
decrease in the ability of the heart to eject blood sufficiently during
contraction. HFpEF is the form of heart failure that occurs when the
left ventricle becomes stiff and though it continues to eject blood
normally, in HFpEF the heart’s ability to relax is reduced, causing it
to be unable to fill with blood sufficiently. The prognosis of patients
with HFpEF is similar to that of HFrEF5. Roughly half of the
patients with heart failure have HFpEF5, for which there are
no approved therapies.
About Cardurion Pharmaceuticals
Cardurion Pharmaceuticals is
a biotechnology company with both clinical and preclinical programs
focused on the development of novel, next-generation therapeutics for
the treatment of heart failure and other cardiovascular diseases. Led by
two physician-scientists with extensive experience in cardiovascular
science, medicine, and drug development, Cardurion Pharmaceuticals’
unique programs and strongly collaborative environment enable the
company to deliver promising treatments that target major unmet
needs. Cardurion Pharmaceuticals has facilities in Cambridge,
Massachusetts and Shonan, Japan. For more information, please visit the
company’s website at http://www.cardurion.com.
Cardurion Pharmaceuticals’ Forward-Looking Statements
This
press release contains forward-looking statements, all of which are
qualified in their entirety by this cautionary statement. Any statements
contained herein that do not describe historical facts, are
forward-looking statements that are based on management’s expectations
and are subject to certain factors, risks and uncertainties that may
cause actual results, outcomes, timing and performance to differ
materially from those expressed or implied by such statements. These
factors, risks and uncertainties include, but are not limited to: the
costs and uncertainties associated with our research efforts and other
discovery activities; the inherent uncertainties associated with the
conduct, timing and results of preclinical and clinical studies of our
product candidates; and the adequacy of our capital resources and
availability of additional funding. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release, and we undertake no obligation to update or revise any of such
statements to reflect events or circumstances occurring after this press
release. We caution readers not to place undue reliance on the
forward-looking statements contained in this press release.
The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
1 Global
Public Health Burden of Heart Failure. Cardiac Failure Review (2017)
2 American
Heart Association, Causes and Risks for Heart Failure (February 2018)
3 Circ
Heart Fail. 2013 May ; 6(3): 606–619. doi:10.1161/HHF.0b013e318291329a
4 American
Heart Association, Heart Disease and Stroke Statistics (January 2017)
5
Owen
et al (2006) N Engl J Med
