Array BioPharma (Array) has reported positive top-line data from a phase 1 clinical trial of its novel small molecule glucokinase activator (GKA) – ARRY-403. The drug met its primary and secondary endpoints of safety, pharmacokinetics and glucose control in patients with type 2 diabetes.
ARRY-403 was evaluated in a phase 1 single ascending dose study. The study included seven dose cohorts with a total of 41 patients with type 2 diabetes, receiving either placebo or single doses of ARRY-403 ranging from 25mg to 400mg.
Reportedly, ARRY-403 was well tolerated at all doses. It was rapidly absorbed, and exposure was dose-dependent. The pharmacokinetic profile is consistent with once daily therapeutic dosing, claims the company.
In addition, ARRY-403 has provided dose-dependent reduction in glucose excursions in response to a standardized meal as well as reduction in 24-hour fasting blood glucose.
Kevin Koch, president and chief scientific officer at Array, said: “These results are encouraging, validating this mechanism-of-action in Type 2 diabetic patients. Unlike current therapies, ARRY-403 enhances insulin production from the pancreas while simultaneously regulating glucose metabolism in the liver. Based on the pharmacokinetic and safety profile, coupled with effective glucose control, we believe ARRY-403 has the potential to be a first-line therapy with once-a-day dosing.”