News | March 08, 2011

Company Plans to Pursue Post-Acute Indication for Heart Failure Drug

March 8, 2011 – Nile Therapeutics is pursuing a new indication for cenderitide, formerly CD-NP. The company is looking to develop the drug as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital.

Within 90 days of admission for ADHF, approximately 40 percent of patients return to the hospital. Post-acute patients need sustained cardiac and renal function support to prevent a recurrence of their acute symptoms. In multiple clinical trials in both acute and chronic heart failure patients, short-term infusion of cenderitide has been shown to have positive effects on cardiovascular and renal parameters.

The continuous and extended infusion of cenderitide through a subcutaneous pump could provide patients with sustained symptomatic relief in the outpatient setting. This could contribute to a reduction in post-acute hospitalizations and persistent improvement in cardiorenal functions.

“With over 1 million admissions per year in the U.S., at a cost of over $33 billion, ADHF is one of our country’s most expensive health problems,” said Richard B. Brewer, Nile’s executive chairman. “We believe that cenderitide has an opportunity to address a true unmet need in heart failure, and could help reduce the overall cost of health care.”

Before the end of the second quarter of 2011, the company plans to file a new Investigational New Drug (IND) application and to initiate a Phase I pharmacokinetics and pharmacodynamics (PK/PD) clinical trial. Following the PK/PD trial, it intends to initiate a Phase II double-blind, placebo-controlled, dose-ranging clinical trial in post-acute heart failure patients in the first half of 2012.

“This new path represents the identification of an opportunity that incorporates the current clinical, scientific, and regulatory perspectives on the development of heart failure therapeutics,” said James Young, M.D., professor and executive dean, Cleveland Clinic Lerner College of Medicine. “Preclinical and clinical data have shown that the natriuretic peptide class can act on multiple disease processes that play a role in the negative outcomes associated with heart failure. The unique properties of cenderitide provide a sound rationale to support this innovative strategy and could lead to the development of a differentiated product with clinically meaningful benefits.”

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