Nile Therapeutics reports positive interim data from heart failure study

The objective of the Phase IIa study is to assess hemodynamic and renal effects of CD-NP in patients with acute heart failure. In this dose escalation trial, stabilized acute heart failure patients receiving standard-of-care heart failure medications were administered an eight-hour infusion of CD-NP at 3ng/kg/min (n=11), followed by a 14-hour washout period, and then an eight-hour infusion of CD-NP at 10ng/kg/min (n=9).

Results from the first cohort of patients show a statistically significant reduction in pulmonary capillary wedge pressure (PCWP). Infusion with 3ng/kg/min of CD-NP resulted in a statistically significant reduction of 2.9mmHg relative to baseline at eight hours (p=0.02). Infusion of 10ng/kg/min CD-NP following a washout period resulted in a further reduction of PCWP, which reached statistical significance at two hours after initiation (p=0.02).

In patients who completed both doses of CD-NP, there was a statistically significant overall reduction in PCWP of 5.4mmHg (p=0.002) from the initial baseline PCWP of 23.7mmHg. The interim results also include an observed trend of decreasing right atrial pressure and increasing cardiac output during intravenous infusion of CD-NP; however, these trends did not reach statistical significance in this initial sample of patients.

Importantly, these favorable hemodynamic effects of CD-NP were observed with minimal changes in blood pressure relative to baseline. No hypotension or clinically significant blood pressure reductions were observed during the study.

Peter Strumph, CEO of Nile, said: “We believe that the results from this patient population will be predictive of activity in our upcoming Phase IIb study in acute heart failure patients. We look forward to announcing the full results from this Phase IIa study, as well as results from the ongoing Phase Ib study in stable heart failure patients.”