The toxicology report will be included in the Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA), which is expected to be submitted in the second quarter of 2012.
The study also established that SPX-106 does not accumulate and is rapidly excreted after multiple days of dosing. This study, in conjunction with earlier efficacy studies, continues to support SPX-106 as a component of a combination therapy for dyslipidemia. Earlier tests have shown reduced dyslipidemia in apolipoprotein E--deficient mice and Syrian Golden hamsters, as well as in LDL receptor-deficient mice. SPX-106T, which is SPX-106 combined with D-tagatose, is thought to treat dyslipidemia by simultaneously blocking carbohydrate conversion to lipids and promoting lipid catabolism (lipid breakdown). This latest study paves the way for the SPX-106T human clinical trial in 2012.
"I am pleased to report the successful achievement of a critical milestone, our first toxicology study of SPX-106. These results advance our current development plan and support our belief that there are significant opportunities for our Company in the development of SPX-106T for the dyslipidemia market," reported Dr. Claire Kruger, CEO of Spherix.