BUSINESS WIRE
-First Clinical Trial of Resolvins-
BEDFORD, Mass.--(BUSINESS WIRE)--Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics
company, today announced that it has initiated the first human clinical
trial evaluating a resolvin therapeutic, RX-10045, in a Phase I/II
clinical trial in patients with moderate-severe dry eye syndrome.
RX-10045 is a synthetic analog of RvE1, a naturally occurring resolvin
with potent anti-inflammatory and cell-sparing activities in laboratory
testing.
"This is an important milestone for Resolvyx, as initiation of this
trial offers the first opportunity to demonstrate the clinical
importance of resolvins as a new class of therapeutics,” said Paul
Rubin, M.D., Chief Executive Officer of Resolvyx. "We are delighted to
have successfully initiated this study, and anticipate receiving data in
the first half of 2009.”
The randomized, multi-center, placebo-controlled, dose-ranging study is
designed to evaluate the safety, tolerability and efficacy of RX-10045
in improving the signs and symptoms of dry eye. Approximately 200
patients will be enrolled in the trial which will evaluate the effects
of RX-10045 on multiple endpoints recognized by the U.S. Food and Drug
Administration (FDA): objective measures of corneal and conjunctival
staining, tear film break-up time, as well as subjective measures of
discomfort.
“Based on its unique mechanism of action and compelling preclinical
data, we are hopeful that RX-10045 will offer a novel therapeutic
approach for the treatment dry eye, a widespread eye disease for which
there is a significant lack of effective therapies,” said, Per
Gjorstrup, M.D., Ph.D., Chief Medical Officer of Resolvyx.
About RX-10045
RX-10045 is Resolvyx’s lead resolvin therapeutic and is an isopropyl
ester pro-drug of the active resolvin compound, RX-10008. Resolvyx has
conducted laboratory studies demonstrating that RX-10008 is effective in
preventing the deleterious effects of dry eye, as well as restoring
healthy cell function. In the same studies, RX-10008 is highly effective
in preventing signs of dry eye, including decreasing corneal
inflammation, reducing corneal epithelial damage, and preventing loss of
goblet cells (the cells responsible for maintaining tear film
integrity). In addition, RX-10008 potently blocks several key
pro-inflammatory mediators in dry eye and to accelerates corneal tissue
repair with an effect level comparable to that seen with epidermal
growth factor (EGF), the most potent previously-known mediator of
corneal tissue repair.
About Dry Eye Syndrome
Dry eye syndrome is one of the most common problems treated by eye
physicians; an estimated 25-30 million Americans suffer from dry eye and
the worldwide prevalence closely parallels that of the United States.
Dry eye is a chronic multifactorial disease of the tears and ocular
surface that results in symptoms of discomfort, visual disturbance, and
tear film instability with potential damage to the ocular surface. It is
accompanied by increased osmolarity of the tear film and inflammation of
the ocular surface. Dry eye can make it more difficult to perform some
visual activities for an extended period of time, and it can decrease
tolerance for dry environments.
About Resolvins
Resolvins are a recently discovered family of naturally-occurring, small
molecule lipid mediators that can be targeted to treat a wide range of
diseases. In particular, resolvins act to protect healthy tissue during
an immuno-inflammatory response to infection, injury or other
environmental challenge, and then act to resolve inflammation and
promote healing after the insult has passed. Resolvins are shown to be
highly potent and efficacious in pre-clinical models of asthma,
atherosclerosis, rheumatoid arthritis, inflammatory bowel disease, dry
eye and retinal disease, among others.
Resolvins are potential drug candidates to treat a broad range of acute
and chronic diseases caused by a failure to resolve the inflammatory
response and restore immune homeostasis. Such diseases include
auto-immune diseases (like Crohn’s disease, psoriasis and rheumatoid
arthritis), allergic diseases (like asthma) and chronic inflammatory
diseases (like atherosclerosis, degenerative retinal diseases, chronic
dry eye and Alzheimer’s disease). Resolvins offer an entirely novel
biological approach to treating significant inflammatory diseases, with
a decreased potential for immuno-suppression.
About Resolvyx Pharmaceuticals
Resolvyx Pharmaceuticals is a privately-held biopharmaceutical company
dedicated to the discovery, development and commercialization of
resolvins, a novel class of therapies to treat inflammatory diseases and
their complications. Resolvyx's drug R&D programs are focused on
characterizing and developing resolvin-based compounds. With its
experienced management team, world-class scientists and leading
investors, Resolvyx is well-positioned to capitalize on its extensive
portfolio of more than 55 patents and applications.
The company's headquarters are in Bedford, Massachusetts. For additional
information, please visit http://www.resolvyx.com.