Another New Class of Hypoglycemics (Sugar Substitutes) Shows Positive Results

Results of the blinded interim data analysis of the Phase 3 trial demonstrate a significant reduction in variability of HbA1c levels, the primary endpoint of the trial. The observed data to-date indicate that the change in variability of HbA1c from baseline is favorable, and that the current sample size gives the study sufficient power to achieve the statistical significance for protocol defined differences between control and D-tagatose in HbA1c when the study reaches the planned number of patients completing treatment.

"The interim results and overall study progress are very encouraging", said Dr. Claire Kruger, Chief Executive Officer of Spherix. "The interim analysis results are significant because they indicate that if this study continues as anticipated, results will support the efficacy and safety of D-tagatose as a new and important therapy for Type 2 diabetes."

"We are particularly pleased that the interim analysis of blinded pooled data from the NEET trial has established that the statistical significance for the pre-specified change in HbA1c, 0.5%, can be achieved with the current sample size." 

The analysis noted that the results of the secondary variables, LDL, HDL, triglycerides, and body mass index (BMI), are very striking and are in agreement with that of the HbA1c results. These results demonstrate a significant decrease in the mean BMI at all time points evaluated compared to baseline. A consistent decrease of BMI and serum triglycerides was observed at each visit. A statistically significant reduction in HDL and LDL was also seen compared to baseline. 

NIH Medline Plus states that, in general, an HbA1c of 6% or less is normal, and diabetic patients should try to keep their HbA1c level at or below 7%. The NEET protocol sets an HbA1c lower limit of 6.6% for randomization into the trial, and an upper limit of 9%. At the time of the interim analysis, not all subjects had finished the entire treatment course of this trial; therefore the number of responders was different for different months of therapy. The incidences of responders achieving an HbA1c target of <6.5% at 1, 2, 4 and 6 months of treatment were 4%, 13%, 19% and 18% respectively. Because the trial is randomized 1:1 in terms of drug and placebo, approximately 50% of the patients receive the placebo treatment. 

The interim analysis is a pooled, blinded analysis, conducted by an independent statistics and regulatory consulting firm, and there is no statistical penalty. The NEET trial is an ongoing double-blind, placebo-controlled clinical study, designed to evaluate the safety and efficacy of D-tagatose for the management of Type 2 diabetes. Pending continuing positive study results and overall progress, Spherix remains on target to complete the Phase 3 clinical trial for D-tagatose and submit a New Drug Application (NDA) in 2010.

Recognized As Safe (GRAS) for use as a sweetener in food, D-tagatose is a Phase 3 candidate for fighting diabetes and would be a new first-in class agent.  If approved, D-tagatose is likely to receive at least five years of market exclusivity as a result of the Hatch-Waxman extension for new chemical entities.