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news.AtheroGenics has said that it will conduct a phase III clinical trial studying the effect of its investigational candidate in patients with type II diabetes.
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Patient enrollment is currently projected to begin in the third quarter of 2007, and the study protocol provides for an interim analysis, which the company expects to occur by mid-2008.
The multi-center double-blind study is designed to compare the effects of the drug, AGI-1067, versus placebo on patients with diabetes. Previous trials have found that the compound significantly lowers both fasting plasma glucose and glycosylated hemoglobin, the two most commonly used measures of glycemic control, the company said.
In addition, there was a strong trend toward benefit in clinically important cardiovascular events in patients with diabetes, with a 22% reduction in the prespecified endpoint of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (heart attack) and stroke. In a related finding, there was a 64 percent reduction in patients developing diabetes for the first time during the study, known as new onset diabetes.
As part of its plan to focus on the upcoming trial, AtheroGenics has taken steps to reduce its employee base by approximately 50%, resulting in a current staff of 67 employees. The one-time costs associated with the restructuring, including non-cash provisions for asset write downs, are estimated to be approximately $3 million.