FDAnews
www.fdanews.com/articles/88802-surface-logix-presents-positive-data-on-dyslipidemia-drug

SURFACE LOGIX PRESENTS POSITIVE DATA ON DYSLIPIDEMIA DRUG

November 17, 2006

Surface Logix announced the presentation of positive data from its first Phase I clinical trial assessing the safety and tolerability and establishing the pharmacokinetic and pharmacodynamic profile of its investigational drug candidate for dyslipidemia, SLx-4090. Results were presented at the American Heart Association's conference in Chicago.

The Phase I, a double-blind, placebo-controlled, randomized, four-way cross-over study enrolled healthy male volunteers. In the study, subjects received single oral doses of either SLx-4090 or placebo. Nine dose levels were included and subjects were monitored for adverse events. Pharmacokinetic and pharmacodynamic sampling was performed out to 24 hours after dosing to measure plasma lipid and lipoprotein concentrations after dietary consumption. The trial indicated that SLx-4090 was well-tolerated, with no serious adverse events reported, and demonstrated a significant impact on lowering triglyceride levels compared with placebo.

SLx-4090 is a novel microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia. Surface Logix designed SLx-4090 using its proprietary small-molecule Pharmacomer Technology to act specifically in the gastrointestinal (GI) tract to prevent the transport of fats through the intestinal wall. This unique feature of intestinal selectivity allows activity against fat uptake while avoiding toxicity at other sites of MTP expression including the liver, heart, testis, ovary and eye, according to the company.