SURFACE LOGIX COMMENCES PHASE 2A CLINICAL TRIAL OF SLX-2101 IN RAYNAUD’S DISEASE
BOSTON, Mass. (June 28, 2007)
– Surface Logix Inc. today announced the initiation of a
Phase 2a clinical trial for SLx-2101 in patients with
secondary Raynaud’s disease.
SLx-2101 is a novel, long-acting PDE-5 inhibitor being
developed for the management of diseases associated with
vascular dysfunction such as Raynaud’s, a vasospastic
disorder of small blood vessels leading to a marked
reduction of blood flow to areas such as the fingers and
toes. Often triggered by exposure to cold, Raynaud’s is
associated with painful blue or white digits, and in
severe cases, may lead to the development of digital
ulcers.
“PDE-5 inhibition holds
promise in several cardiovascular indications, though
many disorders such as Raynaud’s are currently not
addressed by marketed PDE-5 inhibitors,” commented Paul
Sweetnam, Ph.D., Chief Scientific Officer of Surface
Logix. “We used our novel chemistry platform to design
SLx-2101 to have a profile that would deliver fast onset
and long duration of therapeutic effects in
difficult-to-treat conditions such as Raynaud’s,
potentially enabling quicker, longer-lasting relief to
patients.”
“The initiation of this
trial is part of Surface Logix’s multiple indication
development plan for SLx-2101. We believe that it has
applicability in cardiovascular indications beyond
erectile dysfunction and are therefore pursuing its
advancement in specialized indications, such as
Raynaud’s, as well as in larger cardiovascular markets,”
said Jim Mahoney, President and Chief Executive Officer
of Surface Logix.
The
Phase 2a trial is a single European center, randomized,
double-blind, placebo-controlled, crossover pilot study
that will enroll 20 patients with secondary Raynaud’s
disease. The trial is designed to examine the safety,
tolerability and pharmacodynamic profile of repeat oral
doses of SLx-2101 once daily for up to 14 days. The
primary objective of this trial is to investigate the
severity of secondary Raynaud’s disease-related attacks
during the dosing period. Secondary objectives include
evaluating the frequency and total daily duration of
disease-related attacks during the dosing period, the
safety and tolerability of SLx-2101, and the effect of
the drug on capillary blood flow velocity and
vasospastic symptoms.
Surface Logix also initiated a Phase 2a clinical trial
to test the safety, tolerability and pharmacodynamics of
orally administered SLx-2101 in patients with
hypertension in June 2007. 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. 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 in Raynaud’s Disease
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).
Raynaud’s disease is a condition that classically affects the
blood supply to the fingers and toes but may also
involve the nose and ears. During a Raynaud’s attack, or
episode, the blood vessels constrict (narrow) and the
blood supply to these areas is reduced. This results in
skin color changes which are often accompanied by a
throbbing or burning sensation, cold, and numbness. The
exact cause of Raynaud’s disease remains unknown.
Raynaud’s disease occurs more frequently in women than
in men. Although it can occur at any age, it usually
begins between the ages of 15 and 40. It is estimated
that 4 – 5 percent of the United States population is
affected. Secondary Raynaud’s occurs when the Raynaud’s
episodes are associated with a number of underlying
medical conditions such as rheumatoid arthritis and
scleroderma.
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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