Spherix, a developer of proprietary therapeutic products for the treatment of diabetes, metabolic syndrome and atherosclerosis, has successfully completed the 28-day rat toxicology study of its drug candidate SPX-106.
The study demonstrated good safety results with the dosing planned for the first in-human study in the first quarter of 2012, and showed that SPX-106 is rapidly excreted after multiple days of dosing without any accumulation. Prior tests with SPX-106 were shown to reduce dyslipidemia in apolipoprotein E-deficient mice, LDL receptor-deficient mice and Syrian Golden hamsters.
Spherix CEO Claire Kruger said the first toxicology study results of SPX-106 advance their current development plan and support the company in the development of SPX-106T for the dyslipidemia market. The toxicology study findings will be included in the investigational new drug (IND) submission to the US Food and Drug Administration (FDA), which is anticipated to be submitted in the second quarter of this year.
Earlier studies demonstrated that by treating animals using a range of low doses of twice-daily SPX-106T, the combination of D-tagatose and SPX-106 considerably reduced VLDL by 35% and LDL by 18%. In addition, a new study in rats reports that D-tagatose inhibits fructose absorption in the gastrointestinal tract, providing further insight into the mechanism of action of SPX-106T. In apolipoprotein E-deficient mice, SPX-106T showed reduced serum cholesterol by 30%, prevented body weight gain and also minimised the amount of subcutaneous, retroperitoneal and epididymal fat.
The company also initiated the preclinical development of SPX-106T as a treatment for hypertriglyceridemia in one arm of a study intended to assess both D-tagatose alone and in combination with SPX-106T.