SAN FRANCISCO, Feb. 22 /PRNewswire/ -- DiObex, Inc., a privately-held pharmaceutical company focused on the development of therapeutics to treat metabolic diseases, today announced that it has begun treating patients with type 2 diabetes in a randomized, placebo-controlled clinical trial. Patients will be treated for two weeks to evaluate the safety and pharmacokinetics of three dose levels of the Cortisol Synthesis Inhibitor, DIO-902.
There are convincing data supporting the concept that abnormalities in cortisol activity are an important cause of insulin resistance, visceral fat deposition, elevated cholesterol and blood pressure. These abnormalities, commonly present in patients with type 2 diabetes and obese pre-diabetic patients, increase the risk of cardiovascular disease.
“We are very excited at the prospect of continuing human clinical development for this novel Cortisol Synthesis Inhibitor. Many big pharma companies are in hot pursuit of this target and we believe that DIO-902 is at the head of the pack in the advancement of this new and exciting class of drugs,” commented Daniel Green, President of DiObex.
DIO-902 (2S,4R ketoconazole) is one of the two enantiomers contained within the racemate of the drug ketoconazole. A racemate is a mixture of equal quantities of two enantiomers, substances whose molecular structures are mirror images of one another. DIO-902 has been proven to be both more effective and safer than the racemate in preclinical studies.
“The data generated for racemic ketoconazole in patients with type 2 diabetes demonstrated that inhibition of cortisol synthesis provided substantial clinical benefits not only in controlling glucose levels but also in lowering both blood pressure and cholesterol,” said Dr. Timothy Stewart, Vice President of Research at DiObex. “DIO-902 has been shown in preclinical experiments to be responsible for virtually all of the cortisol synthesis inhibitory activity present in the racemate. In addition, DIO-902 has characteristics which, if reproducible in humans, could lead to a drug that is not only more potent, but also substantially safer than the racemate.”
“A drug that helps manage glucose, cholesterol and blood pressure simultaneously would be very important in the management of patients with type 2 diabetes, who are typically treated with multiple medications. We have high hopes that DIO-902 will prove able to meet this need, and the results of our upcoming trial will be important in demonstrating the drug’s safety and pharmacological activity,” said Dr. Bernice Welles, Vice President of Development at DiObex.
“DIO-902 has significant potential as a novel therapeutic agent for the management of type 2 diabetes. Our R&D team has done an impressive job of moving this project into the clinic in less than a year since it was in-licensed,” concluded Prof. Robert Henry, Chief Scientific Officer at DiObex.
About DiObex, Inc.
DiObex, Inc. is a San Francisco-based, venture-financed biotechnology company. The company was founded in 2003 to develop novel products for the treatment of metabolic diseases. The company’s formulation of Very Low Dose Glucagon (VLD Glucagon) is in phase 2 clinical development and has received Fast Track status from the Food and Drug Administration. DiObex’s investors are Domain Associates, Pequot Ventures and Sofinnova Ventures. For more information, visit www.diobex.com.
DiObex, Inc.
CONTACT: Bruce Carlson of DiObex, +1-415-551-4116, or bcarlson@diobex.com
Web site: http://www.diobex.com//
