Lexicon Reports Preliminary Results From Phase 1 Studies Of LX2931 And LX7101

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8/16/2012 6:18 AM ET

Lexicon Pharmaceuticals Inc.(LXRX: Quote) reported preliminary results from Phase 1 studies of LX2931 and LX7101.The Phase 1 study of LX2931, an inhibitor of sphingosine-1-phosphate lyase, was a dose-ranging study to explore higher doses of LX2931 in patients with rheumatoid arthritis. The study involved 10 patients with rheumatoid arthritis, eight of whom were randomized to LX2931 and two to placebo.

The company said that Patients in the study received increasing doses over the course of the study, beginning at 50 mg QD and escalating to 500 mg QD. LX2931 was well-tolerated at all doses evaluated, with no serious adverse events and no withdrawals due to adverse events.

According to the company, Seven of eight patients on LX2931 achieved drug trough levels greater than 60 ng/ml, a pharmacokinetic measure which a post-hoc analysis of data from a prior Phase 2 study of LX2931 had suggested was associated with better responses in American College of Rheumatology or ACR measures in the study. Six of the eight LX2931-treated patients experienced a drop from baseline in the DAS28 score of greater than or equal to 1.2, as did both placebo patients.

ACR20 and ACR50 responses were achieved at varying frequencies in both LX2931-treated and placebo patients, but two of eight patients dosed with LX2931 achieved an ACR70 response during the course of the study, compared to none on placebo.

The Phase 1 study of LX7101, an inhibitor of LIM domain kinase 2 (LIMK2), was a first-in-man study evaluating two doses of LX7101 in glaucoma patients. The study involved 63 patients with glaucoma randomized among two doses of LX7101 (0.125% solution and 0.25% solution, each given as an eye drop) or vehicle.

Patients in the study received a single daily dose of LX7101 or placebo during the first week of the study and two daily doses during the second week. LX7101 was well-tolerated at all doses evaluated, with no serious adverse events and no withdrawals due to adverse events, the company said.

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