Dr. Kruger, CEO, added, "I am proud to report that Spherix has reached a number of key milestones, each of which we hope will increase the potential for the Company to realize its goal of commercializing D-tagatose as a novel treatment option for patients with Type 2 diabetes."
Dr. Lodder, President, elaborated on the results of the compound's recent interim analysis, "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, increasing the statistical power to observe a significant result. 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 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, with the difference in triglycerides becoming significant by the last two patient visits. A statistically significant reduction in HDL and LDL was also seen compared to baseline."
Dr. Kruger concluded the Company's formal remarks by saying, "Turning now to our ongoing and developing commercialization strategy, there is no point in doing clinical trials unless the company plans to market the drug as a result. The Company needed to raise $6.3 million in new capital on Monday
|SOURCE Spherix Incorporated|
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