Shares of Spherix (SPEX) soared 77 percent this morning after the Bethesda, MD-based developer unveiled a positive set of interim Phase III data for its Type 2 diabetes drug. The developer says it's right on track to wrap the study and file for an approval in 2010.
Spherix has evidently hit the sweet spot for experimental diabetes drugs, demonstrating a significant drop in blood glucose levels among the patients taking the drug. Close to eight percent of the U.S. population has diabetes, and the vast majority of those cases are Type 2. In a release, Spherix said that the data "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 Spherix CEO Dr. Claire Kruger. "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."
- check out the Spherix release
- here's the story from Dow Jones