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ARTICLE | Clinical News

EV-077: Additional Phase IIa data

September 3, 2012 7:00 AM UTC

Additional data from the first cohort of 32 Type II diabetics in a double-blind, German Phase IIa trial showed that twice-daily 300 mg oral EV-077 met the primary efficacy endpoint of inhibiting platelet aggregation vs. placebo (p=0.001). EV-077 also improved both macrovascular (43% vs. 20%) and microvascular (108% vs. 25%) endothelial function from baseline to day 29 vs. placebo. Additionally, EV-077 reduced peak albuminuira after exercise from baseline to day 29 vs. placebo in 21 evaluable patients who completed the exercise (54% vs. a 10% increase) and in the overall population (34% vs. a 12% increase). Bleeding time increased to 8.6 minutes on day 29 from 4.4 minutes at baseline in patients receiving EV-077 and to 5.9 minutes on day 29 from 4.9 minutes at baseline in the placebo arm. Evolva said the increased bleeding time is not considered to be "clinically relevant" and is similar to or lower than that observed for several marketed drugs. ...