The Dry Eye Zone

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Drug News: LX214 successful Phase I completion

Sept 23, 2009 - Business Wire
Lux Biosciences Reports Phase 1 Safety Results and Open Label Efficacy Results for LX214, a Potential Best-in-Class Treatment for Dry Eye

JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences, Inc. a privately held biotechnology company focused on the treatment of ophthalmic diseases, today announced results from a Phase 1 human safety and an open-label pilot efficacy study of the company’s potential best-in-class therapy for dry eye, LX214 (topical mixed nanomicellar formulation of voclosporin). Randomized, double-masked, placebo-controlled data from 30 healthy volunteers showed LX214 to be well tolerated at the two doses (0.02% and 0.2%) studied, with safety and tolerability measurements (pain, burning, reddening, photophobia, foreign body sensation and others) indistinguishable from placebo.

An additional cohort of five patients with severe dry eye syndrome was treated with LX214 in both eyes twice a day for 14 days at the target 0.2% concentration. Data from these patients confirmed that systemic exposure to voclosporin was very low and below the threshold level where measurement of voclosporin blood concentrations would be required in future studies. Signs and symptoms of disease were also assessed in this cohort of patients. Despite the small sample size and short duration of treatment, clinically meaningful improvements were noted in both signs (tear production) and symptoms (OSDI index) at both 7 and 14 days, a trend that bodes well for longer term, controlled studies to follow.

“The benign safety and tolerability results in humans demonstrated in both these trials confirm the positive profile exhibited by LX214 in preclinical studies, which showed this drug candidate to establish therapeutic levels in relevant ocular tissues and to be non-irritating when applied topically to the eye,” said Eddy Anglade, M.D., Lux Biosciences’ Chief Medical Officer. “Moreover, even though the 14 day results in severe dry eye patients were based on a small, uncontrolled sample, they presented quite encouraging indicators of efficacy.”

LX214, developed in cooperation with Ashim Mitra, Ph.D., University of Missouri Curator’s Professor of Pharmacy and Director of Translational Research at UMKC School of Medicine School of Pharmacy, University of Missouri-Kansas City, is a proprietary formulation of Lux Biosciences’ next generation calcineurin inhibitor, voclosporin. Utilizing voclosporin and Lux’s proprietary mixed nanomicellar formulation technology, LX214 establishes high levels of drug for 24 hours in relevant ocular tissues following a single administration, including the lacrimal gland and submandibular lymph nodes, suggesting that LX214 may be efficacious and suitable for once daily dosing.