BOSTON, June 6 /PRNewswire/ -- Surface Logix Inc. today announced the initiation of a Phase 2a clinical trial of SLx-4090 in patients with dyslipidemia (abnormal levels of lipids in the bloodstream). The trial will investigate the drug's effect on reducing plasma lipid levels by preventing the intestinal absorption of cholesterol and triglycerides. SLx-4090 is an enterocyte-specific microsomal triglyceride transfer protein (MTP) inhibitor being developed for the treatment of dyslipidemia.
"This study builds on the positive data from Phase 1 trials completed last year, in which SLx-4090 was shown to have a clear impact on reducing the peaks of triglyceride seen after meals and reducing overall levels of LDL," said Jim Mahoney, President and Chief Executive Officer of Surface Logix. "The impressive tolerability and safety profile seen to-date reflects the fact that SLx-4090 works selectively in the gastrointestinal tract but is not absorbed into the blood stream."
"Based on the preclinical data and the effects seen in the Phase 1 trials, SLx-4090 is predicted in longer-term patient studies to reduce LDL cholesterol, impact favorably HDL/LDL ratios, and reduce fasting triglyceride levels," Mahoney continued. "If the data continues as we have seen to date, we believe SLx-4090 will have utility as an additional treatment option for patients who do not reach lipid and triglyceride target levels on current therapies."
The Phase 2a trial is a single center, randomized, double-blind, placebo- controlled study that will enroll 24 patients with dyslipidemia (high cholesterol and triglyceride levels). The primary study objective is to investigate the effect on post prandial plasma triglycerides of repeat oral doses of SLx-4090 for 14 days. Secondary trial objectives are to evaluate the effect of SLx-4090 on additional pharmacodynamic parameters such as HDL, LDL, total cholesterol, and apoB values; and to determine the candidate's safety, tolerability, and pharmacokinetics.
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(TM) 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. Surface Logix is also exploring the use of SLx-4090 in other metabolic disorders, including obesity and diabetes.
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.
About Surface Logix Inc.
Surface Logix Inc. uses its expertise in biophysical chemistry to create and develop novel small molecule drugs (NCE's) with superior intrinsic drug- like properties that are clearly differentiated from competitive products. The company is advancing multiple internal programs focused primarily on cardiovascular, metabolic, inflammatory and fibrotic diseases. For more information, please visit http://www.surfacelogix.com.
Contact: Warwick Tong MB ChB Surface Logix Inc. Senior Vice President, Commercial Development 617.746.8505 Media: Kari Watson MacDougall Biomedical Communications Inc. kwatson@macbiocom.com 508.647.0209
Surface Logix Inc.CONTACT: Warwick Tong MB ChB, Senior Vice President, CommercialDevelopment of Surface Logix Inc., +1-617-746-8505, or Media: Kari Watsonof MacDougall Biomedical Communications Inc., +1-508-647-0209,kwatson@macbiocom.com
Web site: http://www.surfacelogix.com/
