Spherix expects to file an NDA next year.
Spherix reported positive interim Phase III results with its oral type 2 diabetes treatment, D-tagatose. Thus far data demonstrates a reduction in variability of HbA1c levels, the primary endpoint of the trial, according to the company.
NEET (naturlose (D-tagatose) efficacy evaluation 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. The drug works by preventing the stimulation of insulin secretion, avoiding beta-cell exhaustion, and lowering blood glucose levels. Pending continuing positive study results and overall progress, Spherix anticipates completing the Phase III study and submitting an NDA in 2010.
The study protocol set 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 and therefore the number of responders was different for different months of therapy. The incidence of responders achieving an HbA1c target of < 6.5% at 1, 2, 4, and 6 months of treatment was 4%, 13%, 19%, and 18% respectively.
The preliminary analysis also suggested that there was a decrease in the mean BMI and serum triglycerides at all time points evaluated compared to baseline. A statistically significant reduction in HDL and LDL was also seen compared to baseline, Spherix reports.
“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,” states Claire Kruger, Ph.D., CEO of Spherix. “We are particularly pleased that the interim analysis of blinded pooled data from NEET has established that the statistical significance for the prespecified change in HbA1c, 0.5%, can be achieved with the current sample size.
“Some of the currently marketed drugs to control glucose levels may cause patients with type 2 diabetes to experience significant discomfort and develop serious side effects including cardiovascular disease. We believe our therapeutic approach has the potential to offer patients and clinicians an alternative for achieving their therapeutic goals without some of the attendant risks of currently available medications.” GI discomfort was the most common adverse event, with symptoms that were rare, mild, and transient at the beginning of the treatment period.
Joshua L. Cohen, M.D., one of the medical advisory board members, remarks, “Physicians need additional drugs in our armamentarium to treat type 2 diabetes. Because it is already classified as Generally Recognized As Safe for use as a sweetener in food, D-tagatose is an exciting Phase III candidate for fighting diabetes and would be a new first-in class agent.”