BioCentury
ARTICLE | Clinical News

Emapticap pegol: Phase IIa data

April 7, 2014 7:00 AM UTC

A double-blind, international Phase IIa trial in 75 Type II diabetics with albuminuria on current standard of care to control hypertension, hyperglycemia and dyslipidemia showed that twice-weekly 0.5 mg/kg subcutaneous NOX-E36 met the primary endpoint of reducing urinary albumin excretion as measured by the change from baseline to week 12 in mean ACR vs. placebo (30% vs. an increase of 2%, p=0.014). Additionally, 31% of patients receiving NOX-E36 achieved a >=50% reduction in mean ACR vs. 6% for placebo. Noxxon also said the therapeutic effect of NOX-E36 was maintained after cessation of treatment, with the maximum effect on mean ACR observed 8 weeks after the last dose (placebo-adjusted reduction of 39%, p=0.01). NOX-E36 led to a non-significant reduction in HbA1c of 0.32% from baseline to week 12 vs. a 0.06% increase for placebo (p=0.096); the difference in HbA1c between treatment groups became significant at 4 weeks after the last dose (reduction of 0.35% vs. an increase of 0.21%, p=0.036). ...