– GK Activator ARRY-403 Demonstrates Effective Glucose Control –
Array BioPharma Inc. (Nasdaq: ARRY) today announced positive top-line
data from a Phase 1 clinical trial in patients with Type 2 diabetes with
its novel small molecule glucokinase activator (GKA), ARRY-403. The drug
met its primary and secondary endpoints of safety, pharmacokinetics and
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 Kevin Koch,
Ph.D., President and Chief Scientific Officer. “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.”
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 Tuesday, August 11, 2009 at 9 a.m. ET.
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 with 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.
