Nile Therapeutics, Inc. a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, announced plans to pursue a new indication in the field of heart failure. Nile plans to develop cenderitide (formerly CD-NP) 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. This is a novel therapeutic space for natriuretic peptides that has been termed “post-acute.”

Within 90 days of admission for ADHF, approximately 40 per cent 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.

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

“With over 1 million admissions per year in the US, 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.”

Nile recently had a productive meeting with the United States Food and Drug Administration (FDA) on the development of cenderitide as an extended subcutaneous therapy for a post-acute indication. Nile will seek a FDA Fast-Track Approval Designation for this post-acute indication. Before the end of the second quarter of 2011, Nile 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, Nile 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, MD, 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.”

Nile Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs.