Array BioPharma To Present Clinical Results On Diabetes Drug At European Diabetes Meeting

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Oct 2009 - 9:00 PDT

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Array BioPharma Inc. (NASDAQ: ARRY) 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 at: http://www.arraybiopharma.com.

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.

About Diabetes

According to the Centers for Disease Control, approximately 24 million (8 percent) Americans have diabetes. Current therapies for this progressive disease are insufficient or have unwanted side-effects creating a need for the development of novel therapeutic approaches. GKAs, such as ARRY-403, represent a promising new class of drugs for the treatment of type 2 diabetes.

About Glucokinase Activation

In normal individuals, the pancreas secretes insulin in response to increased levels of glucose in the blood. Glucokinase (GK) is the enzyme that senses glucose in the pancreas. GK also increases glucose utilization and decreases glucose production in the liver. In patients with type 2 diabetes, there is a reduction of GK activity in the pancreas and the liver. Activating GK lowers blood glucose levels by enhancing the ability of the pancreas to sense glucose, which leads to increased insulin production. Simultaneously, GKAs increase the net uptake of blood glucose by the liver and decrease the production of glucose by the liver.

About ARRY-403

In multiple well-established preclinical in vivo models of type 2 diabetes, ARRY-403 is highly efficacious in controlling both fasting and non-fasting blood glucose, with rapid onset of effect and maximal efficacy within 5 to 8 once daily doses. When combined with existing standard-of-care drugs (metformin, sitagliptin, and pioglitazone), ARRY-403 provided additional glucose control, and reached maximal efficacy after 5 to 7 once daily doses. ARRY-403 did not increase body weight, plasma triglycerides or total cholesterol, whether used as monotherapy or in combination with other diabetes drugs.

Source
Array BioPharma

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