Biotech Values

[ThomasS]

ARRY 403: We now know one of two new drugs that ARRY plans to introduce into clinical development by YE 2008/1Q 2009. The company has entered a new area, outside of inflammation/cancer:

http://biz.yahoo.com/bw/080925/20080925005178.html?.v=1

Array BioPharma Presents Positive Preclinical Data on Its Glucokinase Activators in Type 2 Diabetes

BOULDER, Colo.--(BUSINESS WIRE)--Array BioPharma Inc. (Nasdaq: ARRY - News) today announced the presentation of preclinical data on a novel small molecule glucokinase activator (GKA), ARRY-403, a drug for the treatment of Type 2 diabetes. The data showed that ARRY-403 demonstrated potent, highly glucose-blood-level dependent, control of both fasting and non-fasting glucose concentrations. Based on these and other results, Array plans to advance ARRY-403 into human clinical studies in the first half of 2009. The data were presented today at an annual metabolic diseases conference in London.
“There is a significant need for new, more effective oral diabetes treatments – and glucokinase activation represents a promising new mechanism,” said Kevin Koch, Ph.D., President and Chief Scientific Officer. “GKAs hold the potential to bring a significant benefit to Type 2 diabetes patients and we believe ARRY-403 is a highly potent and safe glucokinase activator.”

The data showed that in multiple well-established in vivo models of Type 2 diabetes, ARRY-403 was highly efficacious in controlling both fasting and non-fasting glucose, with rapid onset of effect and maximal efficacy within five to eight days. In combination with existing standard-of-care drugs (metformin, DPP4 inhibitor, or PPARγ agonist), ARRY-403 provided additional glucose-control, which reached maximal efficacy after five to seven days of once-daily dosing. ARRY-403 showed no adverse increases of body weight, plasma triglycerides or total cholesterol, whether used as monotherapy or in combination.

According to the Centers for Disease Control, approximately 24 million (8 percent) Americans have diabetes. Current therapies for this progressive disease are insufficient or inconvenient, 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.

The ARRY-403 presentation will be available as a PDF on Array's website: www.arraybiopharma.com.

About ARRY-403/ Glucokinase activation

Glucokinase activators (GKAs) reduce glucose levels via a dual mechanism of action – working in both the pancreas and the liver. Glucokinase (GK) is the enzyme that senses glucose in the pancreatic beta cells, stimulating insulin release in a glucose-dependent manner. GK also regulates glucose uptake and glucose production in the liver. In diabetic patients, there is a reduction of glucokinase (GK) activity in the pancreas and the liver. The activation of glucokinase lowers glucose levels by enhancing the ability of pancreatic beta cells to sense glucose, in turn increasing the level of insulin that is produced by the pancreas. Simultaneously, GKAs also increase the uptake of glucose in the liver, while reducing the amount of glucose produced by the liver. These combined actions of GKAs result in improved beta cell function and increased insulin sensitivity in the liver.