Spherix (SPEX) Reports Preliminary Phase 2 Study Results of Naturlose(R)
Spherix Incorporated (Nasdaq: SPEX) today announced positive preliminary results from a Phase 2 clinical trial of its novel compound, Naturlose(R) (D-tagatose), in the treatment and management of Type 2 diabetes. The Phase 2 trial is expected to be completed in early 2010.
In the ongoing single-blind study designed to establish the minimum dose of Naturlose capable of causing a beneficial effect, Naturlose is administered orally with meals, three times daily at three different doses: 2.5, 5.0, and 7.5 g. The comparator is the 2.5 g dose. The primary endpoint for the study is reduction in HbA1c after 6 months on the drug. After 6 months on drug, the patients in the 7.5 g group experienced an average reduction of 0.3% in HbA1c from the HbA1c of the 2.5 g group. At that same 6-month point, the 5.0 g group averaged a reduction in HbA1c of 0.05% from the 2.5 g group. Naturlose appears to begin showing an effect on HbA1c within the range of doses selected for this minimum-dose study. The ongoing Phase 3 double-blinded study of efficacy is being conducted at a 15 g dose, and is powered to detect a 0.5% reduction in HbA1c.
Over the course of the Phase 2 trial, Naturlose also decreased the average serum triglycerides of the patients by -59 mg/dl by the end of the first month on therapy, a decrease from baseline that remained at -41 mg/dl by the end of the 6 months of the trial. Naturlose also decreased serum LDL by an average -13 mg/dl by the end of the first month on therapy, while serum HDL was essentially unchanged (+0.9 mg/dl). The LDL:HDL ratio was improved for two of the three dose groups by an average of 0.3.
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