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August 19, 2012

Lexicon reports positive preliminary results from Phase I studies of LX2931, LX7101

Lexicon Pharmaceuticals, a biopharmaceutical company, has reported preliminary results from Phase I studies of LX2931 and LX7101 in rheumatoid arthritis patients and glaucoma patients respectively.

Lexicon Pharmaceuticals, a biopharmaceutical company, has reported preliminary results from Phase I studies of LX2931 and LX7101 in rheumatoid arthritis patients and glaucoma patients respectively.

The Phase I dose-ranging study of LX2931, which was designed to explore higher doses of LX2931 in patients with rheumatoid arthritis, involved 10 patients eight of whom were randomised to LX2931 and two to placebo.

The primary endpoint in the study was the safety and tolerability of escalating doses of LX2931 compared with placebo over 12 weeks in subjects with active rheumatoid arthritis, while the secondary endpoints included pharmacokinetic and disease activity measures.

According to the preliminary results, LX2931 was well-tolerated at all doses evaluated, with no serious adverse events and no withdrawals due to adverse events.

Seven of eight patients on LX2931 achieved drug trough levels greater than 60ng/ml and 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.

Lexicon president and chief executive officer Dr Arthur Sands said the results of these studies offer a potential path for evaluating the efficacy of higher doses of LX2931 and demonstrate the potential utility of LX7101’s novel mechanism of action.

"We will be evaluating the results of these studies internally and with prospective partners in determining next steps for these programs," Dr Sands said.

The Phase I study of LX7101 involved 63 patients with glaucoma randomised among two doses of LX7101 (0.125% solution and 0.25% solution, each given as an eye drop) or vehicle.

The safety and tolerability of LX7101 over two weeks was the primary endpoint, while the secondary endpoints included measures of intraocular pressure (IOP), taken at multiple time points on day -1, day 1, day 7 and day 14.

LX7101 was well-tolerated at all doses evaluated, with no serious adverse events and no withdrawals due to adverse events.

Mean IOP changes from baseline at day 14 for each LX7101 dose arm compared to the vehicle at eight hours post-dose were 3.18 mmHg for 0.125% and 2.32 mmHg for 0.25%, compared to 0.40 mmHg for the vehicle.

Reductions from baseline at day 14 in the diurnal mean IOP, representing mean changes across all daily time points, were 3.37 mmHg for 0.125% and 3.52 mmHg for 0.25%, compared to 2.17 mmHg for the vehicle.

 

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