Surface Logix Presents Positive Phase 1 Repeat-Dose Trial Data On SLx-4090
Surface Logix announced the presentation of positive safety and efficacy data from its innovative Phase 1 repeat-dose clinical trial of its investigational drug candidate SLx-4090, a first-in-class enterocyte-specific microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia (abnormal levels of lipids in the bloodstream). The data indicated not only that repeat- dosing at all dose levels of SLx-4090 was well tolerated, with no serious adverse events reported, but also that SLx-4090 significantly decreased plasma levels of both triglyceride and LDL-cholesterol compared to placebo. These data extend earlier findings previously reported from a single-dose study relating to the safety, tolerability and pharmacokinetic and pharmacodynamic profiles of SLx-4090. Results were presented at the 16th International Symposium on Drugs Affecting Lipid Metabolism being held October 4-7 in New York, NY.
"It is exciting that this novel compound continued to perform so well in this first repeat-dose study," said Dr. William Prince, Chief Development Officer of Surface Logix. "Consistent with our preclinical and Phase 1 single-dose results, no drug was detected in the plasma at doses up to 200 mg given three times daily for two weeks. This is particularly notable, as all other known MTP inhibitors have been shown to enter the systemic circulation and negatively impact standard measures of liver function. SLx-4090 was extremely well tolerated and adverse events were similar to those seen with placebo."
"Based on the results of this study, we have advanced SLx-4090 into a Phase 2a study, which will be completed shortly, and initial results are confirming the profile seen in both Phase 1 studies," said Jim Mahoney, President and Chief Executive Officer of Surface Logix. "We are also planning to start a Phase 2b study in patients with dyslipidemia in the middle of 2008. Based on the promising results seen to date, we strongly believe that SLx-4090 could play a significant role in the marketplace by providing clinicians another route to manage lipid disorders for patients who do not adequately respond to currently available treatment options."
Surface Logix is also exploring the use of SLx-4090 in other metabolic disorders, including obesity and diabetes.
SLx-4090 Phase 1 Repeat-Dose Study Design
The SLx-4090 Phase 1 repeat-dose study is a randomized, double-blind, placebo-controlled, dose escalating/dose decreasing study in 10 cohorts of 12 healthy male volunteers each. A variety of dosing regimens were included in the study. For subjects receiving SLx-4090, doses ranged from 25 mg to 200 mg, and dosing frequency in active and placebo arms ranged from once daily to three times daily. Treatment periods ranged from 5 to 14 days.
About SLx-4090 in Dyslipidemia
SLx-4090 is a novel microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia (abnormal levels of lipids in the bloodstream). 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 potent activity against fat uptake while avoiding toxicity at other sites of MTP expression in the body including the liver, heart, testis, ovary, and eye.
Dyslipidemia currently affects approximately 10% of the global population, with 25% of these patients having elevated triglyceride levels. In addition, there is an increasing prevalence and medical need for lipid-modifying drugs in obese patients and patients with type 2 diabetes, as a high proportion of type 2 diabetic patients have abnormal concentrations of lipoproteins. In the U.S., Japan and Europe, it is estimated that there are more than 240 million people with abnormal lipoprotein levels. Of these, more than 55 million are estimated to have low high density lipoprotein (HDL) and/or high triglyceride levels.