Nile Therapeutics announced plans to collaborate with Medtronic on the clinical development of Nile’s proprietary natriuretic peptide, cenderitide (formerly CD-NP), for heart failure and renal disease applications.
“We are very pleased to partner with Medtronic on cenderitide,” said Joshua Kazam, chief executive officer of Nile Therapeutics. “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 hospitalisation for acute heart failure.”
Under the terms of the agreement, Medtronic will fund and provide its drug-device expertise as Nile executes on 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. Financial terms were not disclosed.
Following the phase I study, Nile 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, re-hospitalisation 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 re-admission 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.