BUSINESS WIRE
JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences, Inc. a privately held biotechnology company focused on
the treatment of ophthalmic diseases, today announced results from a
Phase 1 human safety and an open-label pilot efficacy study of the
company’s potential best-in-class therapy for dry eye, LX214 (topical
mixed nanomicellar formulation of voclosporin). Randomized,
double-masked, placebo-controlled data from 30 healthy volunteers showed
LX214 to be well tolerated at the two doses (0.02% and 0.2%) studied,
with safety and tolerability measurements (pain, burning, reddening,
photophobia, foreign body sensation and others) indistinguishable from
placebo.
An additional cohort of five patients with severe dry eye syndrome was
treated with LX214 in both eyes twice a day for 14 days at the target
0.2% concentration. Data from these patients confirmed that systemic
exposure to voclosporin was very low and below the threshold level where
measurement of voclosporin blood concentrations would be required in
future studies. Signs and symptoms of disease were also assessed in this
cohort of patients. Despite the small sample size and short duration of
treatment, clinically meaningful improvements were noted in both signs
(tear production) and symptoms (OSDI index) at both 7 and 14 days, a
trend that bodes well for longer term, controlled studies to follow.
“The benign safety and tolerability results in humans demonstrated in
both these trials confirm the positive profile exhibited by LX214 in
preclinical studies, which showed this drug candidate to establish
therapeutic levels in relevant ocular tissues and to be non-irritating
when applied topically to the eye,” said Eddy Anglade, M.D., Lux
Biosciences’ Chief Medical Officer. “Moreover, even though the 14 day
results in severe dry eye patients were based on a small, uncontrolled
sample, they presented quite encouraging indicators of efficacy.”
LX214, developed in cooperation with Ashim Mitra, Ph.D., University of
Missouri Curator’s Professor of Pharmacy and Director of Translational
Research at UMKC School of Medicine School of Pharmacy, University of
Missouri-Kansas City, is a proprietary formulation of Lux Biosciences’
next generation calcineurin inhibitor, voclosporin. Utilizing
voclosporin and Lux’s proprietary mixed nanomicellar formulation
technology, LX214 establishes high levels of drug for 24 hours in
relevant ocular tissues following a single administration, including the
lacrimal gland and submandibular lymph nodes, suggesting that LX214 may
be efficacious and suitable for once daily dosing.
“We are very pleased by the results of this initial human study, which
supports the potential of LX214 to become a best-in-class therapy in dry
eye, an indication that affects as many as 10 million patients in North
America and Europe,” said Ulrich Grau, Ph.D., President and Chief
Executive Officer of Lux Biosciences. “Lux has been able to transform
voclosporin, a molecule with a mode of action that is applicable to a
variety of ophthalmic diseases, into a pipeline of tailored, proprietary
products that maximizes the value of this asset. LX214, the topical
mixed nanomicellar formulation of voclosporin, was developed and
advanced into clinical testing in less than two years, and we view it as
the ‘crown jewel’ in the earlier stage Lux Biosciences pipeline. In
addition, the mixed nanomicellar technology has now been validated in
humans adding a highly valuable proprietary platform to the Lux
portfolio.”
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused
on the treatment of ophthalmic diseases. The company has a staged
product portfolio that includes potential first-in-class therapies with
a short-term path to commercialization and high revenue potential. The
portfolio includes:
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A submission-stage project, LUVENIQ™, the oral formulation of a
next-generation calcineurin inhibitor (voclosporin) for which positive
phase 3 data have recently been obtained for the treatment of
sight-threatening non-infectious uveitis. The 0.4 mg/kg BID dose was
superior to placebo in reducing active posterior segment inflammation
at both Week 16 (p<0.01) and Week 24 (p<0.05). In a second study,
LUVENIQ at the 0.4 mg/kg BID dose demonstrated a 50% greater reduction
in inflammatory exacerbation rate at 6 months than placebo (p<0.05) in
subjects with medically controlled posterior segment disease.
Increased blood pressure, decreased renal function and hirsutism were
the adverse events observed at a rate of approximately 5% increment
over placebo, overall giving rise to a safety profile that appears
conducive for chronic use. Lux Biosciences is collaborating with the
team at Isotechnika Pharma who invented the molecule and develops it
for other indications.
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A Phase 3 clinical-stage project, LUMITECT™, a silicone matrix ocular
(episcleral) implant that continuously elutes cyclosporine A locally
to the eye for the prevention of rejection in high risk corneal
transplantation. The LUCIDA pivotal clinical program with LUMITECT™,
for the prevention of corneal transplant rejection completed patient
recruitment in March 2009 and first results are expected in late 2009.
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LX214, an innovative topical formulation for dry eye syndrome that has
completed Phase 1 clinical testing. Utilizing voclosporin and Lux’s
proprietary topical mixed nanomicellar formulation technology, LX214
establishes high levels of drug concentration in relevant ocular
tissues and is well tolerated in both animals and human volunteers. In
addition to dry eye, LX214 has potential value in other chronic
inflammatory diseases of the eye, such as 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.
Forward-Looking Statements
This press release is not made on behalf of, or with authorization by,
any other company or issuer of securities. To the extent that this press
release may refer to any other issuer of securities, Lux Biosciences,
Inc. makes no statement and expresses no recommendation or other opinion
about any transaction or potential transaction concerning such
securities.
This press release may contain forward-looking statements, including Lux
Bioscience's belief as to the medical and commercial potential of its
product candidates, Lux Bioscience's plans to pursue business and
regulatory strategy, and Lux Bioscience’s expectations regarding actions
and decisions solely within the control and purview of other parties.
These forward-looking statements involve important known and unknown
risks and uncertainties, which could cause actual results to differ
materially from those in the forward-looking statements. Such risks and
uncertainties include, among others, the exercise of discretion by
regulatory agencies and other parties, the availability to Lux
Biosciences of funds and resources to pursue research and development
projects, the performance of activities and generation of scientific
data by parties other than Lux Biosciences, the ability of Lux
Biosciences to economically manufacture and commercialize its products
once approved, acceptance by the medical community of Lux Biosciences’
products once approved and the availability of alternative therapeutic
agents, approval for reimbursement by third-party payors of Lux
Biosciences’ products once approved, the success and timely completion
of clinical trials and other scientific studies, the ability of Lux
Biosciences and its licensors to defend its and their patents from
infringement by third parties, and the risk that such patents may be
subsequently shown to be invalid or that the practice of such patents
may infringe the patents of others. Further, Lux Biosciences disclaims
any undertaking to issue further press releases or otherwise advice
about changes to these beliefs, plans and expectations.