Abbott unveils Atrasentan Phase 2 study results

Abbott‘s Atrasentan Phase 2 study was a double-blind, dose-ranging, placebo-controlled study of subjects with diabetic nephropathy on stable doses of renin-angiotensin system (RAS) inhibitors for more than 2 months with urinary albumin-to-creatinine ratio (UACR) of 100-3000mg/g.

The study’s primary endpoint was mean change in UACR ratio from baseline to each treatment visit while the secondary endpoint was measured as the proportion of subjects achieving at least a 40% reduction in final UACR levels from baseline.

The Phase 2 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.

Additionally, Atrasentan reduced urine albumin-to-creatinine ratio (UACR) in the 0.75mg and 1.75mg groups vs placebo while the 0.25mg dose had no significant effect.

Reduction from baseline to final UACR was 21%, 42%, and 34% in the 0.25mg, 0.75mg and 1.75mg groups vs 11% in placebo.

Lead investigator for the study Donald Kohan said that several large clinical trials with RAS inhibitors have demonstrated that reductions in albuminuria are associated with a delay in the progression of diabetic nephropathy.

"These study results are encouraging and suggest that Atrasentan may have an additional therapeutic role for albuminuria reduction on top of the current standard of care for patients with type 2 diabetes," Kohan said.

Abbott Dyslipidemia and Renal divisional vice president James Stolzenbach said that longer, outcome-driven clinical trials are needed to establish the safety and efficacy of Atrasentan in diabetic nephropathy, but they were encouraged by the findings from the study and look forward to further evaluating Atrasentan.