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Nile Therapeutics Announces Positive Results from Phase 1b Safety and Pharmacodynamics Study of CD-NP in Patients with Heart Failure
Date:12/9/2008

es up to an MTD of 20 ng/kg/min. Dose escalation was limited by symptoms of hypotension observed at 30 ng/kg/min, which represents a dose of approximately 3- to 6-fold above the anticipated therapeutic range.

Effects on Renal Function

Enhancement of renal function by CD-NP was observed at doses well below the MTD. Notably, no clinically limiting changes in blood pressure were observed at the doses showing the most favorable renal effects.

Renal function from evaluable patients was assessed via biomarkers including serum creatinine and creatinine clearance, the most frequently used surrogate measure of glomerular filtration rate (GFR) and renal function. CD-NP treatment resulted in a statistically significant reduction of serum creatinine. After a 24-hour infusion of CD-NP at 3 ng/kg/min, serum creatinine was reduced by 10% (p=0.03). Infusions of 10 and 20 ng/kg/min resulted in serum creatinine reductions of 10% and 7%, respectively. These changes translated to a statistically significant increase in creatinine clearance using the Cockcroft-Gault formula, with infusions of CD-NP at 3, 10 and 20 ng/kg/min resulting in increases of 10% (p=0.01), 9% (p=0.02) and 7%, respectively.

Consistent with its effect on creatinine clearance, CD-NP elicited a statistically significant reduction of cystatin C, another biomarker of renal function. Infusions of CD-NP at 3, 10, and 20 ng/kg/min resulted in reductions of cystatin-c of 5% (p=0.05), 9% (p=0.05) and 4%, respectively.

Infusion with CD-NP resulted in diuresis similar to that observed with furosemide, a common diuretic used frequently in the management of heart failure patients. The average total urine volume during the 24-hour infusions of CD-NP at 3, 10 and 20 ng/kg/min was 2,738 ml. By comparison, during the 24-hour period prior to CD-NP infusion in which patients received standard doses of furosemide, the avera
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SOURCE Nile Therapeutics, Inc.
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