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 that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) for CRD-733, a Phosphodiesterase-9 (PDE-9) inhibitor in development to improve cardiac function in heart failure patients. Recent evidence supports that inhibition of PDE-9 has the potential to restore heart-protective mechanisms that are dysfunctional in heart failure, as well as improve heart muscle function and size. A Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of CRD-733 in healthy volunteers was recently initiated.
"The advancement of CRD-733 into the clinic is an important milestone for Cardurion as we move our portfolio’s lead program forward toward treatment of heart failure, the most important unmet need in cardiovascular medicine,” said Daniel Bloomfield, M.D., chief executive officer at Cardurion Pharmaceuticals. “Compelling preclinical evidence supports that CRD-733 can enhance cardiac function in both known forms of heart failure. With limited options at present for those living with heart failure, we are excited about the potential for CRD-733 to have a positive impact on these patients.”
Cardurion Pharmaceuticals entered an exclusive licensing agreement with Astellas to develop and commercialize CRD-733 earlier this year.
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 States,2 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.
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)