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 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 surfacelogix.
Surface Logix Inc.
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