Spherix Inc. (SPEX) Announces Positive Results of D-Tagatose Phase 3 in Drug Naive Patients
Spherix Incorporated (NASDAQ: SPEX) today announced positive interim Phase 3 clinical results for the planned review of the NEET (Naturlose (D-tagatose) Efficacy Evaluation Trial) trial of D-tagatose in drug naive patients.
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 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.
"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."
D-tagatose is a novel and natural oral agent being developed as an oral, monotherapy treatment for glycemic control in patients with Type 2 diabetes. D-tagatose prevents the stimulation of insulin secretion, avoiding beta cell exhaustion and naturally lowers blood glucose levels.
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 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.
"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."
D-tagatose is a novel and natural oral agent being developed as an oral, monotherapy treatment for glycemic control in patients with Type 2 diabetes. D-tagatose prevents the stimulation of insulin secretion, avoiding beta cell exhaustion and naturally lowers blood glucose levels.
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