The cost burden of developing drugs specifically for diabetes has increased significantly within the last few years under evolving and more stringent FDA guidelines.  A Spherix-commissioned analysis estimates it would take several additional years of clinical trials and millions of dollars to achieve an NDA filing for tagatose under current guidelines.  Spherix has determined that continued development of D-tagatose as a treatment for Type 2 diabetes requires the involvement of a pharma partner with the resources needed to fund the rest of the development and to bring it to market.  The results from the Phase 3 trial will be pivotal in these negotiations, and Spherix expects that the Phase 3 data will show a robust proof of concept demonstrating safety and efficacy for D-tagatose for Type 2 diabetes, potentially making it an attractive candidate for further development by a pharma company.

"As we seek a partner to pursue the diabetes development, we will be shifting the focus of our own R&D efforts to triglycerides, provided of course that the results we see support earlier findings," said Dr. Kruger.

Update On Tagatose Phase 3 Clinical Trial In Type 2 Diabetes

In line with earlier estimates, the Company will announce the results of its Phase 3 clinical trial of tagatose in the treatment of Type 2 diabetes later this summer.  The Naturlose (D-tagatose) Efficacy Evaluation Trial (NEET) trial was initiated in 2007 and is a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of D-tagatose as a monotherapy as an adjunct to diet and exercise. The study involves 332 patients in the US and India.  The primary endpoint is change in HbA1c, with secondary endpoints including triglyceride, glucose and insulin profiles and changes in body weight.

With the requirement for a separate and much larger safety trial, the safety portion of the current NEET trial is no longer necessary and accordingly was discontinued earlier this month.  "We have been reassured by the fact that, to date, there does not appear to be any significant safety concerns in the Phase 3 trial," says Randy Brown, Chief of Clinical Operations.  "However, we concluded that this trial is not large enough to meet the FDA's new safety requirements.  Therefore, we made a management decision not to continue the Phase 3 trial beyond the 6-month efficacy endpoint.  We're pleased that the study is sufficiently powered for efficacy and are eagerly awaiting the efficacy results in a few weeks."

SOURCE Spherix Incorporated