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news.Dara BioSciences, a development-stage pharmaceutical company, has completed all toxicology studies necessary for entering Phase I clinical trials for its PPAR-delta/gamma agonist, DB959.
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DB959 is a novel insulin sensitizer designed to correct the insulin resistance of Type 2 diabetes. In pre-clinical studies, the drug has demonstrated potent PPAR-delta activity, which the company believes will be beneficial in treating cholesterol and lipoprotein abnormalities in diabetics.
DB959 has also demonstrated two additional benefits in pre-clinical studies – a significant reduction in weight gain of approximately 70% compared to Avandia and synergistic effects on insulin sensitivity arising from both PPAR delta and PPAR gamma activity, the company said.
The company expects to file an investigational new drug application with the FDA for DB959 this quarter in order to launch Phase I clinical trials early in the first quarter of 2009.
John Didsbury, president, chief operating officer and chief scientific officer of Dara BioSciences, said: While our compound, DB959, is a potent PPAR-delta activator, it also utilizes PPAR-gamma activity to help control high blood sugar. DB959 has demonstrated the ability to increase good HDL cholesterol, improve the HDL: LDL ratio, and lower triglyceride levels in pre-clinical studies using dyslipidemic animals.
“With this profile of activities DB959 has the potential to provide a cardiovascular benefit to diabetic patients and be positioned as a leading successor in the branded PPAR-gamma agonist market segment, currently dominated by Avandia and Actos.”