A next-generation calcineurin inhibitor for the treatment of uveitis has entered pivotal trials, according to developer Lux Biosciences (Jersey City, N.J.).
LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to Treatment) consists of three controlled, double masked studies of LX211 in different forms of active uveitis and to investigate its use in maintaining control in patients with quiescent disease, the company said. A total of 45 sites in the U.S. and Europe will participate, with patient enrollment estimated to be 500. Efficacy will be measured at 6 months, assessing the degree of inflammation in the anterior and posterior chambers. The company expects results from the pivotal trials in 2008, with regulatory approval sought in late 2008.
LX211 is exclusively licensed to Lux by Isotechnika (Edmonton, Canada); Isotechnika is developing the compound for psoriasis and solid organ transplantation.
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