BUSINESS WIRE
JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences today announced the completion of enrollment for the
landmark LUMINATE (Luveniq Uveitis Multicenter Investigation
of a New Approach to TrEatment) pivotal
clinical trial program, which is investigating the use of LUVENIQ™
(voclosporin; previously designated LX211) as a corticosteroid-sparing
agent for the treatment of patients with non-infectious uveitis. As
planned, the three randomized, placebo-controlled, double-masked studies
together enrolled a total of about 560 patients at 58 sites in 7
countries.
“We are very pleased to have completed patient
enrollment in an expeditious manner in this largest-ever clinical trial
program in non-infectious uveitis, and thank our clinical investigators
and their staff for their enthusiasm and diligence,“
said Ulrich Grau, Ph.D., Lux Biosciences’
President and Chief Executive Officer. “As
patients in the LUMINATE program are treated and followed for six
months, we expect to complete these studies prior to year-end. If the
studies are successful in demonstrating efficacy and safety, we will
seek regulatory approval for LUVENIQ in 2009.”
In the LUMINATE program LUVENIQ is being examined utilizing inflammation
as an endpoint in both the anterior (front) and posterior (back)
segments of the eye. If approved, LUVENIQ will be the first
steroid-sparing agent to be commercialized for uveitis in the United
States and in most international markets.
About LUVENIQ
LUVENIQ is the oral form of a next-generation calcineurin inhibitor,
voclosporin, to which Lux Biosciences has an exclusive worldwide license
for ophthalmic indications from Isotechnika, Inc., of Edmonton, Canada.
Isotechnika is currently investigating voclosporin in phase 3 clinical
trials in psoriasis patients, and has just recently completed a phase 2b
clinical trial in kidney transplant recipients. The clinical data
gathered to date indicate that this molecule is a potent calcineurin
inhibitor (a biological mechanism demonstrated to provide efficacy in
prevention of organ graft rejection and in a range of autoimmune
diseases) with a wide therapeutic window. In addition to its use in
uveitis, Lux Biosciences is developing this next generation calcineurin
inhibitor in proprietary topical formulations for other ophthalmic
indications, including dry eye syndrome and other chronic inflammatory
ocular surface diseases, and in age-related macular degeneration.
About Uveitis
Uveitis is an autoimmune disease characterized by chronic inflammation
of the eye. Uveitis is an under-diagnosed and under-recognized medical
condition that causes vision impairment, ocular pain, and loss of
vision. Experts estimate that 10% of new cases of blindness in the
United States result from this disease. Approximately 300,000 people
suffer from uveitis in the United States alone, the majority of whom are
affected by anterior uveitis; Lux Biosciences is targeting roughly a
third of the disease population for potential treatment. The only
therapeutic class approved by the FDA for treatment of uveitis is
corticosteroids, which are burdened with multiple side effects, such as
osteoporosis, hyperglycemia, hypercholesterolemia, hypertension, mood
disturbances, and if applied chronically to the eye, cataract formation
and glaucoma.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused
on ophthalmic diseases. The company has a staged product portfolio of
potentially first-in-class therapies distinguished by their short-term
path to commercialization and potential to generate high revenue growth.
The portfolio includes:
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Two Phase 3 clinical-stage projects including: i) LUVENIQ™,
the oral formulation of a next-generation calcineurin inhibitor
(voclosporin) developed as steroid-sparing therapy for the treatment
of non-infectious uveitis, and ii) LX201, a silicone matrix ocular
(episcleral) implant that steadily releases therapeutic doses of
cyclosporine A locally to the eye for the prevention of rejection in
cornea transplant recipients. Both the LUMINATE pivotal clinical
program for LUVENIQ for the treatment of uveitis, as well as the
LUCIDA (Lux Corneal Transplant Implant Development
and Advancement of Therapy) pivotal clinical program with LX201
for the prevention of corneal transplant rejection were initiated in
early 2007 and include sites in North America, Europe and India.
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LX214, a novel topical eye drop formulation currently in IND-enabling
studies with a target date for entry into the clinic in 2008. LX214 is
based on Lux’ proprietary next-generation
calcineurin inhibitor and is targeted towards other chronic
inflammatory diseases of the eye, most notably dry eye syndrome,
blepharitis and atopic keratoconjunctivitis.
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Several earlier stage projects based on proprietary product-enabling
bio-erodible polymer technologies that facilitate targeted and
sustained delivery of molecules to the eye.
For more information on Lux Biosciences, please visit the company’s
website at http://www.luxbio.com.