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CD-NP, is a novel chimeric natriuretic peptide in clinical development for an initial indication of acute decompensated heart failure (ADHF). CD-NP was rationally designed by scientists at the Mayo Clinic's cardio-renal research labs. Current therapies for ADHF, including B-type natriuretic peptide, have been associated with favorable pharmacologic effects, but have also been associated with hypotension and decreased renal function which limit their utility in clinical practice. CD-NP was designed to preserve the favorable effects of current therapies while preventing or attenuating the hypotensive response, and enhancing or preserving renal function.
With CD-NP in development for ADHF, we have the opportunity of a
- novel natriuretic peptide rationally designed to be favorably differentiated from small molecule therapies and other natriuretic peptides,
- a clinical/regulatory development path informed by precedent and published guidelines,
- a well recognized unmet medical need, and
- a commercial opportunity which is poorly served by current therapies.
We are pursuing a targeted approval-enabling clinical development plan which will test the hypothesis of favorable hemodynamic and renal efficacy with the prevention or attenuation of hypotension while enhancing or preserving renal function. Our development timelines lead to an End-Of-Phase-2 meeting with the FDA as early as 2009.
In addition to an initial indication for ADHF, CD-NP has potential utility in other indications which include:
- preservation of cardiac function subsequent to AMI, and
- prevention of renal damage subsequent to cardiac surgery.
HEART FAILURE
Heart Failure (HF) is a chronic condition in which the heart cannot effectively pump enough blood to the body's other organs, either as a result of impaired contractility (systolic heart failure) or impaired relaxation and ventricular filling (diastolic heart failure). The most common cause of heart failure is left ventricular systolic dysfunction, in most cases as a result of end-stage coronary artery disease, either with a history of myocardial infarction(s) or viable but chronically under-perfused myocardium.
HF is a major and growing public health problem affecting 5.3 million Americans, with over 650,000 new cases diagnosed every year. The annual mortality for Heart Failure is 19%. Treatment of Heart Failure generates annual costs of approximately $35 billion, of which approximately $3 billion is spent on drugs and $19 billion is spent in the acute hospital setting. Heart Failure patients frequently suffer acute episodes of Acute Decompensated Heart Failure (ADHF) which require hospitalization. For Americans over 65 years of age, ADHF is the most frequent cause of hospital admission. In recent years, 2.4 million patients in the US were hospitalized with a primary or secondary discharge code of ADHF and the average length of hospital stay is 4.3 days. This incidence of ADHF is almost double the number seen 25 years ago. Subsequent to a discharge for ADHF, the average time to re-admission is 3 months and mortality is high with 12% mortality at 30-days and 33% mortality at 1-year.
The growing Heart Failure population, the large and growing financial expenditure, the increasing incidence of hospitalizations for Acute Decompensated Heart Failure, the high re-admission rates subsequent to Acute Decompensated Heart Failure, the high mortality for Heart Failure and the elevated mortality rates associated with post Acute Decompensated Heart Failure all evidence the unmet need associated with Heart Failure and more specifically with Acute Decompensated Heart Failure.
The use of natriuretic peptides to treat ADHF represented one of the most significant advances in heart failure treatment in recent years however concerns regarding their effect on BP and renal function have limited their use in clinical practice. Second generation natriuretic peptides, such as CD-NP, that have been rationally designed to deliver optimal hemodynamic and renal effects may fulfill the original promise of natriuretic peptide therapy.
References
- American Heart Association. "Heart Disease and Stroke Statistics 2008 Update". Circulation, 2008; 117:e25-e146
- ADHERE Registry - Q1 2006 Final Cumulative National Benchmark Report
- ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult. Circulation, 2005; 112:1825-1852
- Jong, P et al. Prognosis and Determinants of Survival in Patients Newly Hospitalized for Heart Failure. Arch Int Med, 162:1689
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