SURFACE LOGIX COMMENCES PHASE 2A CLINICAL TRIAL OF SLX-2101 IN HYPERTENSION
Company to
advance long-acting PDE-5 inhibitor's development in
cardiovascular indications
BOSTON, Mass. (June 19, 2007)
– Surface Logix Inc. today announced the initiation
of a Phase 2a clinical trial to test the safety,
tolerability and pharmacodynamics of orally
administered SLx-2101 in patients with
hypertension.
SLx-2101 is a novel,
long-acting PDE-5 inhibitor that was designed to
deliver efficacy in a range of cardiovascular
diseases, which were originally viewed as obvious
therapeutic targets for PDE-5 inhibition, including
hypertension.
“SLx-2101 was designed to have a profile that would
deliver efficacy in cardiovascular indications where
other PDE-5 inhibitors have failed,” said Paul Sweetnam,
Ph.D., Chief Scientific Officer of Surface Logix. “The
performance of SLx-2101 in preclinical and early
clinical studies has differentiated it from previous
PDE-5 inhibitors. For example, we confirmed activity 48
hours after a single dose of 10mg, making SLx-2101 the
first PDE-5 inhibitor to demonstrate such prolonged
duration of activity using an objective measure.”
“The early clinical studies have established SLx-2101 as
an active once-daily and well tolerated inhibitor of
PDE-5,” stated William Prince, Ph.D., MB, ChB, FFPM,
Chief Development Officer of Surface Logix. “The
activity of SLx-2101 on endothelial function and blood
pressure combined with once-daily dosing has driven our
decision to start clinical development in hypertension.
We look forward to further exploring SLx-2101 in
indications like hypertension that address large markets
not currently addressed by marketed PDE-5 therapies.”
The pilot Phase 2a trial is a randomized, double-blind,
placebo-controlled crossover study being conducted at
two centers in Europe. The trial is expected to enroll
40 patients who will receive 5mg or 10mg oral doses of
SLx-2101 once daily for up to 14 days. The study
objectives are to determine the effect of SLx-2101 on
placebo-corrected, office-seated peripheral systolic and
diastolic blood pressure, as well as on home monitored
blood pressure.
Interim data from a Phase 2a study of SLx-2101 in
erectile function confirmed its activity 48 hours after
a single dose of 10mg, making it the first PDE-5
inhibitor to confirm such prolonged duration of activity
using an objective measure. Previous Phase 1 studies of
SLx-2101 in healthy male volunteers demonstrated its
favorable safety, tolerability, pharmacokinetics and
pharmacodynamic activity. Additionally, in preclinical
animal models, the candidate was highly potent and
selective, induced rapid cellular and tissue response
and provided an extended duration of action.
About SLx-2101
SLx-2101 is an oral,
potent, selective, fast-onset, long-acting (48 hour)
PDE-5 inhibitor designed specifically to expand the
therapeutic potential of PDE-5 inhibition beyond
erectile dysfunction into larger cardiovascular (CV)
markets. SLx-2101 was designed using Surface Logix’s
proprietary chemistry platform, the Pharmacomer
Technology Platform, to have a combination of potency,
selectivity, tissue distribution and half-life, which
optimizes its potential for once-daily utility in the
vascular tissues involved in major cardiovascular
diseases.
The clinical experience of SLx-2101 to date establishes the PK range of
the PDE-5 inhibitor, as well as demonstrates
efficacy in established models of endothelial function
(peripheral arterial tone and erectile function).
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
http://www.surfacelogix.com
Contact:
Leland Webster, Ph.D., M.B.A.
Surface Logix Inc.
Vice President, Corporate Development
617.746.8520
Media:
Kari Watson
MacDougall Biomedical Communications Inc.
kwatson@macbiocom.com
508.647.0209
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