With respect to safety assessments, CD-NP (placebo, 10, 17.5 and 25 ng/kg/min) had no effect on mean arterial pressure versus baseline (-5%, 6%, -6%, -8% average change, respectively), had no effect on serum potassium levels versus baseline (0%, -2%, 3%, 3% average change, respectively), and had no effect on renal function as measured by GFR versus baseline (1%, 8%, 3%, 4% average change, respectively).
The four-hour infusion of CD-NP was well tolerated in all subjects at all dose levels tested. At the highest dose (25 ng/kg/min) of CD-NP, after completing the four-hour infusion, in response to an orthostatic challenge, some subjects exhibited transient symptoms consistent with volume depletion and/or vasodilatation including dizziness, asymptomatic tachycardia and orthostatic hypotension. These events are indicative of a practical limit of pharmacologic activity in normal healthy subjects, and Nile intends to investigate higher doses in upcoming Phase 1b studies of CD-NP infusions in heart failure patients.
"In this trial in healthy subjects, we demonstrated that CD-NP can be safely administered and elicits pharmacological and clinical effects which are consistent with the proposed mechanism of action. We are planning additional phase 1 trials in heart failure patients with the goals of determining the therapeutic dose range for diuresis, natriuresis, and cardiac filling pressure reducing effects, while maintaining systemic blood pressure and preserving renal function," commented Peter Strumph, Chief Executive Officer of Nile.
CD-NP is a rationally-designed synthetic peptide designed to
incorporate the optimal components of naturally occurring natriuretic
peptides, creating a novel compound with unique actions in vivo. CD-NP is a
|SOURCE Nile Therapeutics, Inc.|
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