Lexicon Pharmaceuticals reports preliminary results from two phase 1 studies (Lexicon) - Aug 16, 2012 - P1, N=10; NCT1417052; LX2931 was well-tolerated at all doses evaluated (beginning at 50mg QD & escalating to 500mg QD), with no serious AEs & no withdrawals due to AEs; 7 of 8 pts on LX2931 achieved drug trough levels greater than 60ng/ml; ACR20 & ACR50 responses were achieved at varying frequencies in both LX2931-treated & placebo patients; 2 of 8 pts dosed with LX2931 achieved an ACR70 response during the course of the study, compared to none on placebo
P1 data • Rheumatoid Arthritis
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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 primary endpoint in the study was an evaluation of the safety and tolerability of escalating doses of LX2931 compared with placebo over 12 weeks in subjects with active rheumatoid arthritis. Secondary endpoints included pharmacokinetic and disease activity measures...
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. 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 (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...
(IR5)
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