SLx-4090 is Company's First Clinical Candidate for Disorders Related to
Dyslipidemia
CHICAGO and BOSTON, Nov. 14 /PRNewswire/ -- Surface Logix Inc. today
announced the presentation of positive data from its first Phase 1 clinical
trial assessing the safety and tolerability and establishing the
pharmacokinetic and pharmacodynamic profile of its investigational drug
candidate, SLx-4090, an enterocyte-specific microsomal triglyceride
transfer protein (MTP) inhibitor being developed for the treatment of
dyslipidemia (abnormal levels of lipids in the bloodstream). Results were
presented at the American Heart Association's Scientific Sessions 2006
conference being held November 12 - 15 in Chicago, Illinois.
During the presentation, Dr. William Prince, Chief Development Officer
at Surface Logix, provided details of the SLx-4090 Phase 1 study, a
double-blind, placebo-controlled, randomized, four-way cross over study in
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 post dose to measure plasma lipid
and lipoprotein concentrations after dietary consumption. The initial Phase
1 trial indicated that SLx-4090 was well tolerated, with no serious adverse
events reported, and demonstrated a significant impact (>60%) on lowering
triglyceride levels compared to placebo.
"It is exciting that this novel compound performed so well in this
Phase 1 study," notes Dr. Prince. "Consistent with our preclinical results,
no drug was detected in the plasma at doses up to 800mg and no adverse
events occurred that were distinguishable from placebo. This is
particularly notable, as it has historically been difficult to design an
MTP inhibitor that acts selectively in the gastrointestinal tract with no
adverse impact on liver or liver function."
"Based on the results of this study, we have advanced SLx-4090 into a
Phase 1b repeat-dose study, which will be completed by December, 2006, and
initial results are confirming the profile we have seen in our first
study," notes Jim Mahoney, President and Chief Executive Officer of Surface
Logix. "We will commence Phase 2a studies directed at patients with
dyslipidemia complicated by high triglyceride levels early in 2007. Based
on the impact of SLx-4090 in lowering LDL-cholesterol and raising
HDL-cholesterol in preclinical studies, we strongly believe that a safe,
efficacious, enterocyte-specific MTP inhibitor could play a significant
role in the marketplace by providing clinicians another route to manage
lipid disorders for patients that do not respond to currently available
treatment options."
Surface Logix is also exploring the use of SLx-4090 in other metabolic
disorders, including obesity and diabetes.
"The SLx-4090 development program continues to validate our Pharmacomer
Platform and our ability to take novel approaches to overcome difficult
challenges in drug development," states Paul Sweetnam, Chief Scientific
Officer at Surface Logix. "We are very pleased to see that the preclinical
development of SLx-4090 has been very robust in predicting the drug
candidate's performance in the clinic."
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.
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 new small molecule drugs that are optimized to meet the challenges
of human physiology. 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.
Contacts:
Warwick Tong MB ChB
Surface Logix Inc.
Senior Vice President, Commercial Development
617.746.8505
Media:
Kari Watson
MacDougall Biomedical Communications, Inc.
508.647.0209
SOURCE Surface Logix Inc.
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Related links:
http://www.surfacelogix.com
CONTACT:
Warwick Tong MB ChB, Senior Vice President,
Commercial Development, of Surface Logix Inc., +1-617-746-8505;
or Kari Watson of MacDougall Biomedical Communications, Inc.,
+1-508-647-0209
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