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Nile Therapeutics Inc  announced plans to collaborate with Medtronic Inc on the clinical development of Nile’s proprietary natriuretic peptide, cenderitide (formerly CD-NP), for heart failure and renal disease applications. Nile focuses on the development of novel therapeutics for heart failure patients. Financial terms were not disclosed.

Under the terms of the agreement, Medtronic will fund and provide its drug-device expertise for the combination product as Nile executes  its Phase I clinical trial to assess the pharmacokinetics and phamacodynamics of cenderitide delivered through Medtronic diabetes pump technology. In the planned clinical trial, cenderitide will be delivered to heart failure patients for up to 24 hours through continuous subcutaneous infusion. Nile expects to complete the trial by the first quarter of 2012. 

Following the Phase I study, Nile says that it intends to initiate a larger Phase II double-blind, placebo-controlled, dose ranging study in patients admitted to the hospital for acute heart failure. The planned Phase II study will evaluate the endpoints of cardiac remodeling, renal function, rehospitalization, and mortality in patients following 90 days of continuous therapy via subcutaneous pump. The first 90 days following admission to the hospital is a critical time for heart failure patients who are known to have combined rates of readmission and mortality as high as 50% during that period. Nile believes that the cardiac unloading and renal preserving properties of cenderitide could have a significant benefit to patients during a critical time in their recovery from acute heart failure.

“We are very pleased to partner with Medtronic on cenderitide,” says Joshua Kazam, Nile’s chief executive officer. “This collaboration will be an important step on our path to developing cenderitide as a potential new therapy for patients with cardiovascular and renal disease following hospitalization for acute heart failure.”

According to Nile, preclinical and clinical data have shown that the natriuretic peptide class, to which cenderitide belongs, can act on multiple disease processes that play a role in the negative outcomes associated with heart failure.