Lux Biosciences Completes Enrollment In LUMINATE Pivotal Trial Program For Novel Uveitis Therapy, LUVENIQ™

Main Category: Eye Health / Blindness
Article Date: 27 Jun 2008 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Lux Biosciences 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:

- 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.

- 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.

- Several earlier stage projects based on proprietary product-enabling bio-erodible polymer technologies that facilitate targeted and sustained delivery of molecules to the eye.

Lux Biosciences