Lux Biosciences, Inc.
JERSEY CITY, N.J., February 4, 2010
-- Lux Biosciences, Inc. today announced its submission of simultaneous
regulatory filings to both the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) seeking marketing approval for its
investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of
noninfectious uveitis involving the intermediate or posterior segments of
the eye. Efficacy of LX211 in support of the indication sought was
demonstrated in two controlled, randomized, multi-center trials including
data from 450 patients at 56 sites in 7 countries. The safety data include a
total of 2,110 subjects who received voclosporin during its clinical
development in uveitis and psoriasis, about 500 of whom were treated for >36
weeks and about 200 for >52 weeks. LX211 had previously received orphan drug
status from FDA and EMA, and fast track status from FDA. Based on the
latter, Lux Biosciences has requested priority review from FDA.
“The results seen in the LUMINATE clinical trial program, the largest
completed to date in non-infectious uveitis, support our belief that LX211
has the potential to significantly advance the treatment of this blinding
disease,” said Ulrich Grau, Ph.D., Lux Biosciences’ President and Chief
Executive Officer. “This is the first regulatory filing of voclosporin in
any indication, in any country, which made this submission a complex task.
It incorporates the research and development undertaken by our collaboration
partner Isotechnika over more than a decade, and that of Lux Biosciences
over the last 3 ½ years. Simultaneous filings of both a U.S. New Drug
Application (NDA) and a European Marketing Authorization Application (MAA)
for LX211 represent a major milestone for Lux Biosciences.”
He added, “I wish to thank all of the Lux Biosciences employees, our partner
Isotechnika, investigators, patients, contractors and advisors who
contributed to the development program and made these on-time filings
possible. I am not aware of a company of our small size having accomplished
a submission of this magnitude for a new molecular entity simultaneously in
the United States and Europe. It is a tribute to our networked approach to
development, whereby a large team led and managed by a small core group was
able to complete a major international drug development program in record
time.”
Results from the LUMINATE program, submitted in support of both the U.S. and
European marketing applications, showed that LX211 at the recommended dose
of 0.4 mg/kg twice daily provided clinically meaningful efficacy and enabled
preservation of vision in treated patients, a critical patient benefit.
Study LX211-01, in subjects with uncontrolled uveitis, showed LX211 to
rapidly reduce inflammation in subjects with moderately severe disease,
either alone or in combination with systemic corticosteroids. Subjects
receiving LX211 experienced a 50% reduction in mean vitreous haze as
compared to 29% in placebo-treated subjects. The proportion of subjects
demonstrating an improvement of at least 2 grades in vitreous haze or a
grade of ≤1+ for the study eye at last visit was 64% in the LX211 group as
compared to 46% in the placebo group. Moreover, treatment with LX211
permitted the withdrawal of immunosuppressive therapy and the use of 5
mg/day or less of prednisone.
Study LX211-02
demonstrated the efficacy of LX211 in subjects whose disease was clinically
quiescent at the time of enrollment. Nearly 90% of the patients in this
study were receiving one or more forms of systemic immunosuppression prior
to randomization. In this study, treatment with LX211 resulted in a 50%
reduction in the rate of inflammatory exacerbations at the 26-week primary
endpoint compared to those receiving placebo; a similar result was observed
at 50 weeks. This indicates that relative to placebo, a patient’s exposure
to ocular inflammatory exacerbations that lead to loss of vision and to
potentially damaging exposure to high rescue doses of steroids is
approximately cut in half when LX211 therapy is administered at the
clinically effective dose. Treatment with LX211 also enabled the concomitant
withdrawal of immunosuppressive therapy and allowed the reduction of
systemic corticosteroids to 5 mg/day or less, as well as the complete
elimination of topical corticosteroid therapy.
The most common adverse events (>5%) occurring at a rate higher in treated
patients than those receiving placebo, regardless of whether they were drug
related or not, were hypertension, decreased renal function, diarrhea,
pyrexia and arthralgia. All cases of reported hypertension were treatable,
and all cases of decreased renal function were reversible. The most commonly
observed infections reported were nasopharyngitis, urinary tract infection,
and upper respiratory infections, but no opportunistic infections were
observed. Adverse event risks in general did not appear to be increased with
longer-term use. Additionally, no meaningful signals of more serious
treatment effects were observed, even at a lesser frequency, in either
study.
“LX211 at the recommended dose of 0.4 mg/kg twice daily, possesses a
favorable benefit-risk profile for the treatment of noninfectious uveitis
involving the intermediate or posterior segments of the eye,” said Eddy
Anglade, M.D., Lux Biosciences Chief Medical Officer. ”If approved, LX211
would offer physicians a valuable oral treatment option capable of modifying
the course of uveitis by effectively controlling the inflammation that
characterizes this potentially blinding eye disease and significantly
reducing its rate of recurrence. Avoiding inflammatory exacerbations that
result in ocular morbidity and the loss of vision, coupled with avoidance of
steroid-induced morbidities, is central to the management of patients
afflicted with uveitis. LX211 has been shown to provide a means to attain
these therapeutic goals in a disease that requires effective intervention
and for which current therapeutic options are limited and deficient.”
About LUVENIQ™
LUVENIQ (LX211) is the oral form of a next-generation calcineurin inhibitor,
voclosporin. Like other molecules of this class, the compound reversibly
inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it
also inhibits lymphokine production and release. Lux Biosciences has
exclusive worldwide rights to voclosporin for ophthalmic use and is
cooperating with the team at Isotechnika Pharma who discovered the molecule
and develop it in psoriasis and organ transplantation.
About Uveitis
Uveitis, which represents a group of serious inflammatory eye conditions, is
inevitably associated with either severe vision loss or substantial
morbidity from steroid use. Non-infectious uveitis involving the posterior
segment of the eye is a leading cause of vision loss and long-term
disability and the fourth leading cause of legal blindness in the
industrialized world. As the majority of uveitis patients are first
diagnosed at ages under 40 years, the socio-economic burden of this disease
is higher than that of other serious ocular conditions such as AMD and
diabetic macular edema.
About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on
the treatment of ophthalmic diseases. Its submission stage project LUVENIQ
(LX211) is the oral formulation of a next-generation calcineurin inhibitor (voclosporin)
for which positive phase 3 data have been obtained for the treatment of
sight-threatening non-infectious uveitis. The company has several earlier
stage projects based on its mixed nanomicellar ocular formulation
technology, and based on its 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
www.luxbio.com.
Lux Biosciences cautionary statement regarding
forward-looking statements
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.
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