BOSTON, Oct. 5 /PRNewswire/ -- Surface Logix, Inc. today 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(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 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.
About Surface Logix, Inc.
Surface Logix, Inc. uses its expertise in biophysical chemistry to
create and develop novel small molecule drugs (NCEs) 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:
Leland Webster, Ph.D., M.B.A.
Surface Logix Inc.
Vice President, Corporate Development
617.746.8520
Media:
Sarah Cavanaugh
MacDougall Biomedical Communications, Inc.
scavanaugh@macbiocom.com
508.647.0209
SOURCE Surface Logix, Inc.
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Related links:
http://www.surfacelogix.com
CONTACT:
Leland Webster, Ph.D., M.B.A., Vice
President, Corporate Development of Surface Logix Inc.,
+1-617-746-8520; or Media: Sarah Cavanaugh of MacDougall
Biomedical Communications, Inc., +1-508-647-0209,
scavanaugh@macbiocom.com, for Surface Logix Inc.
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