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news.Nile Therapeutics has dosed the first acute setting heart failure patient in its Phase IIa, multi-center, open-label, ascending dose clinical study of the company's lead product candidate, CD-NP, a chimeric natriuretic peptide, in development for the treatment of acute decompensated heart failure.
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The primary objective of the Phase IIa study is to assess hemodynamic effects of intravenous infusions of CD-NP in patients with heart failure.
Key assessments include measurement of pulmonary capillary wedge pressure, plasma cGMP, a secondary messenger of the target receptor, blood pressure, heart rate, serum potassium and renal function. Nile expects up to 30 heart failure patients will be enrolled in the trial.
In parallel with the Phase IIa study, Nile is completing its Phase Ib study of CD-NP. The primary objectives of the Phase Ib study are to assess the safety and tolerability of intravenous infusions of CD-NP in patients with heart failure. Results from both the Phase Ib and Phase IIa trials are expected to be available in 2008.
Peter Strumph, CEO of Nile, said: “We look forward to rapidly enrolling this Phase II trial and to further investigating the clinical effects of this novel, rationally designed, chimeric natriuretic peptide.”