Data supports potential use of DIO-902 with Atorvastatin
SAN FRANCISCO, April 1, 2008 /PRNewswire/ -- DiObex, Inc., a privately held biotechnology company focused on the development of therapeutics to treat metabolic diseases, announced today that a scientific poster relating to DIO-902 (levdexketoconazole) is being presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting on Saturday, April 5th in Orlando. DIO-902 is being studied in Phase 2b clinical trials for the treatment of type 2 diabetes.
The poster, entitled "Differential Effects of Co-Administration of Racemic Ketoconazole and Levdexketoconazole on the Pharmacokinetic Profile of Atorvastatin," highlights the results of a study evaluating the effects of equal doses of the single enantiomer DIO-902 and racemic ketoconazole, on the pharmacokinetics of a single 80 mg dose of atorvastatin in healthy volunteers. Overall, repeated oral administration of DIO-902 tablets with atorvastatin was safe and well tolerated; in addition, DIO-902 significantly reduced cortisol levels compared with ketoconazole.
"The increase in total exposure of atorvastatin was significantly less when it was administered with DIO-902 than with racemic ketoconazole," said Dr. Tim Stewart, Vice President of Research at DiObex. "In addition, the administration of DIO-902 with atorvastatin resulted in significantly reduced cortisol levels from placebo, compared with atorvastatin administered with racemic ketoconazole. This finding supports preclinical evidence that DIO-902 is a more potent inhibitor of cortisol synthesis than ketoconazole."
DIO-902 is an oral, single enantiomer of ketoconazole, a common anti-fungal drug. DiObex is developing DIO-902 as a novel cortisol inhibitor for treating type 2 diabetes and diabetic nephropathy. There is growing evidence linking abnormal cortisol metabolism to both type 2 diabetes and metabolic syndrome, prompting a search for therapeutic agents that lower levels of cortisol or block the effects of cortisol excess. Preclinical and clinical data indicate that DIO-902 is a potent cortisol inhibitor. Clinical data also show early trends toward reductions in HbA1c, total cholesterol, LDL cholesterol, and C-reactive protein. Preclinical and clinical data also suggest that DIO-902 may be a safer and more effective agent than racemic ketoconazole.
DiObex, Inc. is a privately held biotechnology company developing novel products for diabetes and metabolic diseases. DiObex has two product candidates in four mid-stage clinical development programs. DIO-901 (very low dose glucagon) is in development for the prevention of insulin-induced hypoglycemia in type 1 diabetes mellitus in an extended release subcutaneous formulation and in a convenient disposable subcutaneous delivery device. DIO-901 has received Fast Track status from the FDA. DIO-902 (levdexketoconazole) is an oral, single enantiomer of ketoconazole that is a novel cortisol synthesis inhibitor in development for type 2 diabetes mellitus and diabetic nephropathy. Abnormalities in cortisol activity may play an important role in the development of metabolic syndrome, a constellation of conditions that place people at high risk for type 2 diabetes mellitus and cardiovascular disease. For more information, visit http://www.diobex.com.
|SOURCE DiObex, Inc.|
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