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Abbott reports encouraging Phase II data on atrasentan for treatment of diabetic kidney disease.

M2 PHARMA-November 23, 2010-Abbott reports encouraging Phase II data on atrasentan for treatment of diabetic kidney disease(C)2010 M2 COMMUNICATIONS

23 November 2010 - US pharmaceuticals and medical devices maker Abbott (NYSE: ABT) reported yesterday promising results from a Phase II dose-ranging study of atrasentan, a highly selective endothelin A receptor (ETAR) antagonist in development to help slow chronic kidney disease (CKD) progression in patients with Type 2 diabetic nephropathy (diabetic kidney disease).

Study results suggest that atrasentan, used in conjunction with renin-angiotensin system (RAS) inhibitors, may reduce albuminuria (presence of protein in urine) for patients with Type 2 diabetes. Albuminuria is the main sign of diabetic nephropathy and as kidney function decreases, the level of albumin in the urine rises. Results were presented at the annual American Society of Nephrology meeting in Denver, Colorado, the company added.

Data from the eight-week study of three doses of atrasentan (0.25 mg, n=22; 0.75 mg, n=22; 1.75 mg, n=22) vs. placebo showed that atrasentan significantly reduced urine albumin-to-creatinine ratio (UACR) in the 0.75 mg and 1.75 mg groups vs. placebo (P=0.001 and P=0.011 by repeated measures, respectively). The 0.25 mg dose had no significant effect. Reduction from baseline to final UACR was 21%, 42%, and 34% in the 0.25 mg, 0.75 mg and 1.75 mg groups vs. 11% in placebo (P=0.292, P=0.023 and P=0.080, respectively).

A statistically significant proportion of subjects achieved >40% reduction in UACR from baseline in the 0.75 mg group vs. placebo (50% vs 17% respectively, P=0.029). The proportion of patients in the 0.25 mg and 1.75 mg groups (30% and 38% respectively) did not reach statistical significance. Peripheral edema (primarily mild) was the most common adverse event (14%, 18% and 46% for 0.25, 0.75 and 1.75 mg with p=0.007 for 1.75 mg vs. 9% in placebo).

The study was a double-blind, dose-ranging, placebo-controlled study of 89 subjects with diabetic nephropathy on stable doses of renin-angiotensin system (RAS) inhibitors for >=2 months with urinary albumin-to-creatinine ratio (UACR) of 100-3000 mg/g, eGFR >20 mL/min/1.73m2, and NT-pro-BNP <=500 pg/mL.

Patients were equally randomised to placebo, atrasentan 0.25, 0.75, or 1.75 mg daily for eight weeks. The study's primary endpoint was mean change in UACR ratio from baseline to each treatment visit. The secondary endpoint was measured as the proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline.

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