Fort Lauderdale, FL (May 4, 2009): Uveitis, or inflammation within the eye, is a group of diseases responsible for years of visual loss roughly comparable to that caused by diabetes. Now, results from a pioneering international Phase 3 program in uveitis, the LUMINATE trials sponsored by Lux Biosciences, demonstrate the ability of LX211 (LUVENIQ™, voclosporin oral capsule) to significantly improve this chronic eye inflammation. Additionally, in patients who are discontinuing potentially toxic medications for uveitis, such as the corticosteroid prednisone, LX211 actively reduces the rate of inflammatory exacerbations by 50% at six months, compared to placebo. The study results also show a safety profile for LX211 at the 0.4 mg/kg bid dose that suggests the experimental drug would be suitable for chronic use as the first oral treatment for this sight-threatening inflammatory eye disease, while also providing a means to greatly reduce the serious health risks associated with long-term corticosteroid use. LX211 is a novel and proprietary next-generation calcineurin inhibitor that Lux Biosciences is developing for ophthalmic uses.
Dr. James T. Rosenbaum, M.D., Professor of Ophthalmology, Medicine and Cell Biology and Vice-Chair of the Department of Ophthalmology of the Casey Eye Institute – Oregon Health Sciences University (OHSU), represented the LUMINATE Investigator Network in presenting the Phase 3 LUMINATE program results for the first time at the 2009 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). The LUMINATE program, consisting of three randomized, double-masked, dose-ranging and placebo-controlled trials that enrolled a total of 558 patients at 56 sites in 7 countries (United States, Canada, United Kingdom, France, Germany, Austria and India), is the largest clinical program ever conducted in uveitis.
"Uveitis, a term used to classify a group of autoimmune diseases characterized by chronic inflammation of the eye, is the 4th leading cause of blindness and often affects patients under the age of 40, but the disease remains frequently mistreated," commented Dr. Rosenbaum. "Uveitis has many causes and experts often disagree about what constitutes successful treatment. Accordingly, no pharmaceutical company previously has attempted to demonstrate that an oral medication can successfully treat uveitis, and there are currently no FDA-approved oral medications for this condition. Treating physicians often prescribe corticosteroids, which are burdened with a variety of serious systemic side effects when given orally. Even if applied as drops to the eye, corticosteroids can cause cataract formation and glaucoma. Based on the results of the LUMINATE trial program, LX211 appears to offer a therapeutic and safety profile that would meet the critical need for an oral medication for uveitis. LX211 is not a corticosteroid, but allows the reduced use of corticosteroids like prednisone, which in turn reduces the serious side-effects associated with those drugs."
Dr. Rosenbaum noted that a poster presentation at ARVO from a survey of U.S. ophthalmologists and rheumatologists from 27 states, presented by researchers from the Wilmer Eye Institute of Johns Hopkins University, Baltimore, found that the dose of oral corticosteroids used commonly to keep chronic inflammation within the eye under control is in the range of 25 mg/day. This compares to a recommended chronic dose by the uveitis community of 10 mg/day or less. Of additional note, patients enrolled in the LX211-02 protocol, which evaluated the use of LX-211 in subjects with treated but quiescent disease, received doses of corticosteroids that were more than 50% higher than this recommendation. It is well documented that systemic steroids at doses above 10 mg/day cause a myriad of adverse effects, such as osteoporosis, resulting in increased risk for hip or spinal fractures, and metabolic disturbances including obesity, heart disease, and diabetes. Mood disturbances are also associated with chronic corticosteroid use.
"The tapering of systemic corticosteroids to 5 mg or less per day, as implemented successfully in the LUMINATE studies, provides for additional safety from steroid morbidities," Dr. Rosenbaum commented.
"We are pleased with the demonstrated clinical effect of LX211 (Luveniq™) in uveitis, coupled with what appears to be an acceptable side effect profile while reducing the need for systemic corticosteroid to half of the current guideline recommendation," commented Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer. "We're now pursuing regulatory filings, and if approved for commercialization by the appropriate regulatory agencies, LX211 would become the first agent in this class available in the United States and most other markets for the treatment of uveitis."
For more information on uveitis, its incidence, and how the disease is currently treated, please see http://www.luxbio.com/Uveitis%20Backgrounder.pdf
Overview of LUMINATE Trial Results
The LUMINATE program consists of three protocols that included 218 patients with active non-infectious uveitis with posterior (behind the lens of the eye) manifestation of the disease (LX211-01); 232 patients with clinically quiescent disease (LX211-02); and 108 patients with active uveitis with anterior (front of the eye) manifestation of the disease (LX211-03). Data from these trials showed:
The LUMINATE program was conducted under the sponsorship of Lux Biosciences.
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:
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.
CONTACTS:
Lux Biosciences, Inc.
Ulrich Grau, Ph.D.
+1 201-946-0221
Ulrich.grau@luxbio.com
Kureczka/Martin Associates (media)
Joan Kureczka
+1 415-821-2413
Mobile +1 415-690-0210
Jkureczka@comcast.net