SURFACE LOGIX PRESENTS POSITIVE PHASE 1 TRIAL DATA ON SLx-4090 AT AMERICAN HEART ASSOCIATION (AHA) ANNUAL MEETING
BOSTON, Mass. (November 14, 2006) – 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™ 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.
Contact:
Warwick Tong
Senior Vice President, Commercial Development
617.746.8500
Media:
Kari Watson
MacDougall Biomedical Communications Inc.
508.647.0209 |