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.
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.
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)