BUSINESS WIRE
-- Acceptance of PIP Is Pre-Requisite for European Approval --
JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences today announced that the Pediatric Committee of the
European Medicines Agency (EMEA) has issued a positive opinion on Lux’s
Pediatric Investigation Plan (PIP) for LUVENIQ™ (oral formulation of
voclosporin), the company’s potential first-in-class product in Phase 3
development for sight-threatening non-infectious uveitis. The PIP covers
children and young adults between the ages of 2 and 17 years who are
affected with uveitis. An accepted PIP is a pre-requisite for European
approval of new drugs according to legislation passed in January 2007.
The aim of the legislation is to facilitate the development of new
medicines for children without subjecting them to unnecessary clinical
trials or delaying the authorization of those medicines for use in
adults.
“Uveitis is a chronic inflammatory disease of the eye that affects
relatively few children compared to adults,” commented Ulrich Grau,
Ph.D., Lux Biosciences’ President and Chief Executive Officer. “However,
children face an even greater risk of blindness from uveitis than do
adults, as the rate and spectrum of sight-threatening complications are
significant and persist over time. Physicians today rely on
corticosteroids to help control uveitis, but the chronic use of
corticosteroids at the doses required to hold the disease in check is
burdened with serious side effects, such as bone loss, metabolic
disturbances, weight gain, depression and many others. Thus, the need
for new steroid-sparing therapies for this disease is as critical for
children as it is for adults.”
Lux Biosciences completed patient enrollment in mid-2008 in its LUMINATE
(Luveniq Uveitis Multicenter Investigation
of a New Approach to TrEatment) pivotal
clinical trial program, which is investigating the use of LUVENIQ in
adult patients with non-infectious uveitis. Data from the LUMINATE
program, which consists of three randomized, placebo-controlled,
double-masked studies that together enrolled a total of about 560
patients at 58 sites in 7 countries, are expected in Q1 2009. Pending a
positive outcome of the LUMINATE Phase 3 trials and subsequent approval
by U.S. and European regulatory agencies, LUVENIQ will provide the first
steroid-sparing therapy for uveitis.
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.
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 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
sight-threatening 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 corneal 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.
Enrollment in the LUMINATE program was completed in June 2008.
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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 early 2009.
LX214 is based on Lux’s 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.