Lux Biosciences today announced the presentation of preclinical data demonstrating the safety and pharmacokinetics of LX214 as a potential once-daily topical treatment for chronic inflammatory diseases of the eye. LX214 is a clear, micellar, topical formulation of voclosporin, a next-generation calcineurin inhibitor licensed by Lux Biosciences from Isotechnika, Inc. (Edmonton, AB, Canada), which Lux Biosciences is developing as a potential treatment for such conditions as dry eye syndrome, blepharitis, and atopic keratoconjunctivitis.
Lux Biosciences researchers and collaborators presented the data in a poster session at the ARVO Summer Eye Research Conference, “Ocular Immunity and Inflammation” held from July 31 – August 2 at the Portola Plaza Hotel in Monterey, CA. Highlights of the data included:
— Concentrations of LX214 (and/or residue) establish therapeutic levels in tear fluid and most ocular tissues, including conjunctiva, cornea, eyelids, sclera and lacrimal gland after single or multiple topical applications of the experimental drug. Blood levels of LX214 remained at or near base line, and there was minimal distribution of LX214 to the opposite, non-treated eye.
— Tissue concentrations of LX214 in the target tissues for ocular immune-mediated diseases were significantly higher than the tissue concentrations of cyclosporine A achieved by twice daily topical application of Restasis(R) (cyclosporine 0.05%). These results are particularly important given that voclosporin has been shown to be four-fold more potent than cyclosporine A.
— No evidence of clinical irritation was observed in any of the animals treated with LX214.
— No evidence of melanin binding by LX214 was observed.
“These data strongly support the further development of LX214 as a topical product for serious ocular inflammatory conditions as well as for dry eye syndrome,” said Ulrich Grau, Ph.D., President and Chief Executive Officer of Lux Biosciences. “We believe that the product has best-in-class potential based on the preclinical findings.”
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(TM), 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. Enrollment in the LUMINATE program was completed in June 2008.
— 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.
For more information on Lux Biosciences, please visit the company’s website at http://www.luxbio.com.
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