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Cardurion Pharmaceuticals Presents Preclinical Data for CRD-733 at the American Heart Association Scientific Sessions and Announces Initiation of Phase 1b Study in Patients with Heart Failure

November 12, 2018

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 12, 2018--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 worldwide 1  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 admissions 2  and costs approximately $30 billion dollars each year to treat 3. Not only are these costs expected to rise to almost $70 billion by 2030 3, the incidence of heart failure is projected to rise 46 percent – resulting in more than 8 million people with heart failure in the United States 4. 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 HFrEF 5. Roughly half of the patients with heart failure have HFpEF 5, 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.

Global Public Health Burden of Heart Failure.  American Heart Association, Causes and Risks for Heart Failure (February 2018)Circ Heart Fail. 2013 May ; 6(3): 606–619. doi:10.1161/HHF.0b013e318291329aAmerican Heart Association, Heart Disease and Stroke Statistics (January 2017)5Owen et al (2006) N Engl J Med

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KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Cardurion Pharmaceuticals

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PUB: 11/12/2018 09:00 AM/DISC: 11/12/2018 09:01 AM

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