Nile has reported the dosing of its first patient in a phase 2 clinical study of its lead product, CD-NP, for the treatment of acute heart failure.
The single-blind, placebo-controlled study is designed to provide additional information on the safety and tolerability of CD-NP, when infused for up to 72 hours in patients with acute heart failure and mild-to-moderate renal insufficiency.
The study is expected to enroll approximately 30 to 40 patients in the US, Germany and Israel, and will examine up to three doses of CD-NP.
Nile expects to announce interim results of the study later this year, with results from the full study to be available in 2010.
Joshua Kazam, CEO of Nile, said: “This trial is a step forward toward our understanding of CD-NP in acute heart failure patients with renal compromise. We expect results from this study to provide important information about the safety and pharmacologic activity of CD-NP in the intended patient population, and will guide dose selection for a larger Phase 2b study in acute heart failure.”