On the Radar…

Array Biopharma Inc announced positive top line results from a Phase 1 clinical trial of ARRY-403, a novel small molecule glucokinase activator. The 41 patients with Type 2 diabetes in the study were given either a placebo or a single dose of ARRY-403, ranging from 25 mg to 400 mg. Results indicated ARRY-403 met both its primary and secondary endpoints for safety, pharmacokinetics (PK), and glucose control. The drug was well tolerated at all doses, demonstrated a PK profile consistent with once-daily dosing, provided a dose dependent reduction in glucose excursions (changes in glucose concentration) after a standardized meal, and reduced 24-hour fasting blood glucose. ARRY-403 provides a dual mechanism of action both enhancing insulin production in the pancreas and regulating glucose metabolism in the liver. Array is initiating several ascending dose studies to evaluate the safety and efficacy of drug over a 10 day period. ARRY-403 represents Array’s only diabetes treatment currently in human trials; the company, based in Boulder, Colorado, has several molecules in Phase 2 trials for cancer and inflammatory conditions.