Spherix Phase 2 diabetes clinical trial determines minimum D-tagatose dose capable of reducing HbA1c

Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Phase 2 diabetes clinical trial, designed to determine the minimum dose of D-tagatose capable of reducing HbA1c, found that the minimum dose capable of affecting HbA1c (7.5 g three-times daily, or TID) was within the range of doses tested (2.5, 5.0, and 7.5 g TID), with the 2.5 and 5.0 g doses producing similar responses to one another, and the 7.5 g dose producing a greater response.

In addition, by the end of the six-month trial, the 7.5 g dose reduced serum triglycerides vs. the 2.5 g dose by -42 mg/dl from a mean of 180 mg/dl in the Evaluable Efficacy (EE) population. The reduction in serum triglycerides became statistically significant in the Intent-To-Treat (ITT) population at three months of treatment.

In the single-blind study designed to establish the minimum dose capable of causing a beneficial effect, three different doses of D-tagatose were administered to patients orally with meals TID. The comparator was the 2.5 g dose. The study was designed with a minimum of 34 patients in each of the three groups for a total of 102 evaluable patients. The primary endpoint for the study was reduction in HbA1c after six months of treatment. In the minimum dose range, D-tagatose produced a -0.3% reduction in HbA1c in the 7.5 g dose group vs. the 2.5 g dose group in the EE population, from a mean randomization HbA1c of 7.4%. The reduction of the 7.5 g dose was 0.2% more than the 2.5 g dose in the ITT population.

Unlike other drugs, D-tagatose lowered triglycerides without elevating LDL. In fact, D-tagatose in the 7.5 g dose reduced LDL vs. the 2.5 g dose by -11 mg/dl by the third month of treatment, although the difference was not statistically significant. The reduction essentially held steady at the six-month end-of-study visit (-10 mg/dl). HDL was unchanged, increasing only between 0.3 and 1.4 mg/dl over the entire course of the study vs. comparator. Analysis of patient subgroups in the U.S. and India with elevated body mass and/or HbA1c is in progress.

"The decrease in triglycerides of more than 20% in patients with a mean serum triglycerides level that is not even in the High category supports our decision to begin an aggressive drug development program with D-tagatose in hypertriglyceridemia, atherosclerosis and the metabolic syndrome," said Dr. Claire L. Kruger, CEO of Spherix. "We are encouraged by the statistically significant reduction in triglycerides in the ITT population, which is usually difficult to achieve because patients in this population need only receive a single dose in the entire trial in order to qualify. However, this token dose requirement allows a larger number of patients into the ITT population, which in turn makes it easier to detect a smaller change with statistical significance in a minimum dose range finding trial."