BOSTON, Jan. 8 /PRNewswire/ -- Surface Logix today announced positive
results in the Company's Phase 2a clinical trial of SLx-2101 in
hypertension. The randomized, double-blind, placebo-controlled crossover
Phase 2a study in 60 patients with uncontrolled hypertension demonstrated
that SLx-2101 caused clinically significant reductions in blood pressure
and was well tolerated. The trial was designed to examine the safety,
tolerability and effect on blood pressure in patients of repeat oral doses
of SLx-2101 once daily for up to 14 days.
"These data confirm the promise of efficacy seen in earlier clinical
trials, and we plan to initiate a Phase 2b study of SLx-2101 in
hypertension in the third quarter of 2008," said Jim Mahoney, President and
CEO of Surface Logix. "We believe that with our demonstrated 24-hour
coverage from once daily dosing and excellent tolerability profile, we will
be able to uniquely position SLx-2101 in several segments of the
hypertension market."
SLx-2101 is an oral, potent, selective, fast-onset, long-acting PDE5
inhibitor. Other PDE5 inhibitors have traditionally been used to treat
erectile dysfunction (ED). SLx-2101 was designed specifically to expand the
therapeutic potential of PDE5 inhibition beyond ED into larger
cardiovascular markets such as hypertension. SLx-2101 is uniquely
positioned among the known PDE5 inhibitors to address cardiovascular
disease because, compared to currently marketed PDE5 drugs, SLx-2101
preferentially distributes into cardiovascular tissue. With its large
volume of distribution, SLx-2101 achieves sustained plasma levels and a
long duration of action, without showing accumulation upon repeat dosing.
This allows for daily or on demand dosing with a predictable response in a
number of cardiovascular disorders that currently marketed PDE5 therapies
cannot adequately address.
"To achieve efficacy in cardiovascular disease, your compound has to
get into the right tissues," commented Dr. Paul Sweetnam, Chief Scientific
Officer at Surface Logix. "By leveraging our deep understanding of how
small molecules interact with a variety of lipids and proteins, we
succeeded in creating a drug candidate that is able to access PDE5 in
cardiovascular tissue in a physiologically meaningful way. These Phase 2a
clinical results of SLx-2101 demonstrate the translation of this property
into therapeutic activity in hypertensive patients, a first for a PDE5
inhibitor."
The results from the trial provide further confirmation for the
Pharmacomer(TM) Technology Platform designed by Surface Logix scientists to
engineer specific PK and tissue distribution properties into a molecule
while optimizing potency and selectivity. The design of SLx-2101 and its
development program were directed to differentiate SLx-2101 from other PDE5
inhibitors based on the combined features of potency and an extended
duration of action.
About the trial:
The Phase 2a study of SLx-2101 was a randomized, double-blind,
placebo-controlled crossover trial, and was conducted at two centers in
Europe. A total of 60 patients with uncontrolled hypertension, who were
concurrently taking up to 3 marketed anti-hypertensive medications,
received 5 mg or 10 mg oral doses of SLx-2101 once daily for up to 14 days.
In addition to showing the safety and tolerability of the compound in these
dosing regimens, blood pressure monitoring using standard measures (office
seated & standing, central, home, and ambulatory) demonstrated that
SLx-2101 caused clinically significant reductions in blood pressure.
About SLx-2101
SLx-2101 is an oral, potent, selective, fast-onset, long-acting PDE5
inhibitor designed specifically to expand the therapeutic potential of PDE5
inhibition beyond erectile dysfunction into larger cardiovascular markets
such as hypertension. Clinical experience with SLx-2101 to date, including
in ED, confirms its ability to positively impact endothelial function in a
wide range of tissues. SLx-2101 is uniquely positioned among the known PDE5
inhibitors to address cardiovascular disease because, compared to currently
marketed PDE5 drugs, SLx-2101 preferentially distributes into
cardiovascular tissue. By virtue of its large volume of distribution,
SLx-2101 achieves sustained plasma levels and a long duration of action,
without showing accumulation upon repeat dosing. This superior product
profile allows for daily or on demand dosing with a predictable response in
a number of cardiovascular disorders that currently marketed PDE5 therapies
cannot adequately address. Surface Logix is also currently conducting a
Phase 2a study of SLx-2101 in secondary Raynaud's disease, a vasospastic
condition in which PDE5 inhibition has been shown to have a therapeutic
benefit. Preclinical data obtained in models of heart failure suggest that
SLx-2101 has potential in this indication as well.
About Surface Logix, Inc.
Surface Logix, Inc. uses its expertise in biophysical chemistry to
create and develop novel small molecule drugs (NCEs) with superior
drug-like properties that are clearly differentiated from competitive
products. The company is advancing multiple internal programs focused
primarily on cardiovascular, metabolic, oncologic 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
781-235-3060
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., +1-781-235-3060,
scavanaugh@macbiocom.com, for Surface Logix, Inc.
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