Positive results from Nile's cenderitide Phase 1 trial on chronic heart failure

Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced results from its recently completed Phase 1 clinical trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. Nile is developing cenderitide as a 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure (ADHF), referred to as the "post-acute" treatment period.

The Phase 1 clinical trial was designed to understand the doses required to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. The target cenderitide plasma levels were based on Nile's previous Phase 2 clinical trials in which cenderitide was delivered through continuous intravenous infusion.  In total, 58 patients were enrolled in the clinical study.

Results

• The primary end-point was met – cenderitide achieved target PK levels when delivered through Medtronic, Inc's subcutaneous pump technology;
• 24-hour subcutaneous delivery of cenderitide through Medtronic's pump technology was well-tolerated, with no injection site irritation;
• Subcutaneously delivered cenderitide has an acceptable bioavailability profile;
• Cenderitide's PK profile achieved steady-state when delivered through subcutaneous infusion;
• Weight-based dosing reduced PK variability, as compared to a fixed dosing regimen.

"We are very excited about these results. This is the first time we have shown it is feasible to dose cenderitide subcutaneously and to target desirable plasma levels," said Hsiao Lieu, MD, Executive Vice President of Clinical Research at Nile. "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."