Spherix Inc. reported progress on a Phase 3 clinical trial for its new drug to treat Type 2 diabetes and expects results in the third quarter of 2010.
Spherix is developing D-tagatose, which is used to reduce blood sugar levels in patients suffering from Type 2 diabetes. D-tagatose works by decreasing glycogen utilization in the body, which leads to better control of blood sugar.
Spherix has two clinical trials underway for D-tagatose with the Food and Drug Administration (FDA) under the Investigational New Drug Application (NDA) format with the agency. The company has a Phase 2 trial to evaluate D-tagatose for use at lower doses, and a Phase 3 trial to evaluate the safety and efficacy of the drug.
D-tagatose is a naturally occurring sugar that is approved by the FDA as a Generally Recognized As Safe (GRAS) food ingredient. Spherix holds the patents on the use of D-tagatose to treat Type 2 diabetes.
Spherix has signed a manufacturing supply agreement with Inalco S.p.A. to produce large scale quantities of D-tagatose if the drug is approved for use by the FDA.
For more information on the company, go to www.spherix.com