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Nile Phase I trial of cenderitide meets primary end-point

Nile Therapeutics has announced positive results from Phase I trial of cenderitide in patients with chronic heart failure.

The trial was designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide.

The study met its primary end-point, cenderitide achieved target PK levels when delivered through Medtronic’s subcutaneous pump technology.

According to the study, 24-hour subcutaneous delivery of cenderitide through Medtronic’s pump technology was well-tolerated, with no injection site irritation.

Cenderitide’s PK profile achieved steady-state when delivered through subcutaneous infusion.

Nile clinical research executive vice president Hsiao Lieu said for the first time the company has shown that it is feasible to dose cenderitide subcutaneously and to target desirable plasma levels.

"We look forward to starting our next Phase 2 proof of concept trial, in which we hope to show an improvement in clinical heart failure surrogate markers and a potential trend in the reduction of the hospital re-admission rate," Lieu added.