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 surfacelogix.
Surface Logix Inc.
surfacelogix
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