Oct 2 2009
Array BioPharma Inc. (NASDAQ: ARRY) today announced that a poster on ARRY-403, a novel, oral, glucokinase activator (GKA), will be presented at the European Association for the Study of Diabetes annual meeting, on October 2, 2009, in Vienna, Austria. The poster will provide preclinical and Phase 1 single ascending dose (SAD) clinical data on ARRY-403. The poster will be available as a PDF after it is presented on Array's website.
The data presented are consistent with the positive top-line results announced in August 2009 showing that ARRY-403 met its primary and secondary endpoints of safety, pharmacokinetics and glucose control in a Phase 1 SAD study. The study included seven dose cohorts, with a total of 41 patients with type 2 diabetes who received either placebo or a single dose of ARRY-403 ranging from 25 mg to 400 mg. ARRY-403 was well tolerated at all doses. ARRY-403 was rapidly absorbed, and exposure was dose-dependent. The pharmacokinetic profile is consistent with once-daily therapeutic dosing. ARRY-403 provided dose-dependent reduction in glucose excursions in response to a standardized meal as well as reduction in 24-hour fasting blood glucose.
Based on these positive results, Array initiated a multiple ascending dose study and recently started dosing patients with type 2 diabetes to evaluate safety, exposure and glucose control over a 10-day period.
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