Lux Biosciences Reports Positive Results from LUMINATE Phase 3 Program of LX211 (LUVENIQ) in Uveitis
JERSEY CITY, N.J.--(BUSINESS WIRE)--Mar 26, 2009 - Lux Biosciences, Inc. today reported the results from the three phase 3 LUMINATE trials of the company's LX211 (LUVENIQ™, voclosporin oral capsule) drug candidate for the treatment of uveitis. The data show a positive effect on ocular inflammation and a safety profile consistent with the expected use of LX211 in this indication. Following full analysis of the data, the results of the LUMINATE clinical trials will be submitted for publication and presented at upcoming conferences. In parallel, the company will be preparing submissions for approval.
“The available results from the LUMINATE program demonstrate that LUVENIQ, if approved, can play a significant role in the treatment of inflammation in certain forms of sight-threatening uveitis,” said Eddy Anglade, M.D., Lux Biosciences' Chief Medical Officer. “A significant unmet therapeutic need exists for an approved agent which is not a corticosteroid and allows sparing of those drugs to reduce their associated, serious side effects.”
The three randomized, double-masked, dose-ranging and placebo-controlled trials comprising the LUMINATE Program, the largest clinical program ever conducted in uveitis, enrolled 558 patients at 56 sites in 7 countries (United States, Canada, United Kingdom, France, Germany, Austria and India). The trials included 218 patients with active non-infectious uveitis with posterior manifestation of the disease (LX211-01), 232 patients with clinically quiescent disease (LX211-02), and 108 patients with active uveitis with anterior manifestation of the disease (LX211-03). The key results in the LUMINATE trials were:
The integrated safety profile of 0.4 mg/kg BID LX211 in the LUMINATE trials suggests that it would be suitable for chronic use in this high medical need indication. Of particular interest were the relatively small effects of LX211 0.4 mg/kg BID on renal function, an area of concern for first-generation calcineurin inhibitors. The proportion of subjects experiencing a confirmed rate of decrease in estimated glomerular filtration rate (eGFR) by ‰¥30% was 8.2% in the 0.4 mg/kg BID dose group vs. 2.7% in the placebo group. Patients experienced a mean increase in systolic blood pressure by study-end over baseline of 6 mm Hg. However, most of these patients were successfully controlled with medication and only 1.3% discontinued therapy due to hypertension. Other adverse events typical of the calcineurin inhibitor class, in particular diabetes, elevation of lipids, hypomagnesemia, and tremor, were not observed in the LUMINATE studies. Other more frequently observed adverse events included headache, diarrhea and infections, which were similar in incidence to placebo. In terms of ocular safety there was no apparent effect on intraocular pressure, cataract formation or endothelial cell density.
Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer, said, “Based on the available data from the LUMINATE pivotal trial program, we plan to engage in discussions with several regulatory agencies and plan regulatory filings of LUVENIQ in the near future. We are gratified by what appears to be a robust clinical effect of LUVENIQ coupled with an acceptable side effect profile.”
LX211 is designed for use as an oral immune-modulatory agent to treat the forms of non-infectious uveitis that require systemic treatment, including posterior, intermediate and panuveitis, allowing for tapering of systemic corticosteroids to 5 mg or less per day. The mean age of these patients is approximately 40 years and uveitis is the 4th leading cause of blindness; hence, the burden of disease is relatively higher than for age-related ophthalmic diseases, and the medical need for effective treatments is striking.
LX211 (voclosporin oral capsule) is a novel and proprietary next-generation calcineurin inhibitor licensed by Lux Biosciences for ophthalmic use from Isotechnika, Inc. (Edmonton, Canada). If approved for commercialization by regulatory agencies, LX211 would be the first corticosteroid-sparing agent available in the United States and most other markets for the treatment of 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 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:
For more information on Lux Biosciences, please visit the company's website at http://www.luxbio.com.
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Posted: March 2009