Array Publicizes Oral Glucokinase Activator Outcomes in Type 2 Diabetes Patients

Array BioPharma Inc. has recently notified the public of their Phase 1 favorable top-line clinical trial data, conducted with a group Type 2 diabetes patients and their small molecule glucokinase activator (GKA), ARRY-403.  The drug has completed the final primary and secondary processes of safety, pharmacokinetics and glucose control.

ARRY-403 was assessed in a Phase 1 single ascending dose study.  The study contained 41 patients who suffer from Type 2 Diabetes, they received either a placebo or 25 mg to 400 mg of single doses of ARRY-403, the group was divided into 7 dose cohorts.

The clinical trial has found that ARRY-403 was well managed at all doses, absorbed quickly, and exposure was dose-dependent.  Once daily therapeutic dosing produced consistency with pharmacokinetic.  As well as the activator supplied dose-dependent decrease in glucose excursions in response to a conventional meal, and decrease in 24-hour fasting blood-glucose.

Array has arranged a multiple ascending 10-day dose study of Type 2 Diabetes patients, in order to safely gauge exposure and glucose control.  The company intends on publicizing the entire Phase 1 clinical trial findings in the beginning of 2010.