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|Array BioPharma Reports Positive Results of Its Oral Glucokinase Activator in Type 2 Diabetes Patients|
– GK Activator ARRY-403 Demonstrates Effective Glucose Control –
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 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.
Array is initiating a multiple ascending dose study in patients with Type 2 diabetes to evaluate safety, exposure and glucose control over a 10-day period. The Company plans to report the combined Phase 1 results at an upcoming scientific meeting during the first half of 2010.
“These results are highly encouraging, validating this
mechanism-of-action in Type 2 diabetic patients,” said
Additional data will be available from Array BioPharma’s website at www.arraybiopharma.com
and will be discussed during Array’s previously scheduled Fiscal
Year-end conference call on
According to the
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.
In multiple well-established 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.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our future plans for advancing certain of our
proprietary drug programs, the timing and scope of our plans to grow our
clinical development and commercialization capabilities, the potential
to earn future milestone payments, license fees or royalty revenue, the
potential for the results of ongoing preclinical and clinical trials to
support regulatory approval or the marketing success of a drug
candidate, and the plans of our collaborators to further develop drugs
we have out-licensed or on which we are collaborating. These statements
involve significant risks and uncertainties, including those discussed
in our annual reports filed on form 10-K, our quarterly reports filed on
Form 10-Q, and in other reports filed by Array with the
Array BioPharma Inc.