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December 3, 2013
06:06 EDTLXRXLexicon completes Phase 2 study of LX1033 in IBS-d
Lexicon Pharmaceuticals announced top-line results from an initial Phase 2 study exploring the use of LX1033 in diarrhea-predominant irritable bowel syndrome, or IBS-d. LX1033 is an investigational drug that inhibits serotonin synthesis in the gastrointestinal tract. Serotonin is a neurotransmitter that has been shown to play a role in the symptoms of irritable bowel syndrome. The primary endpoint of this study was the change in stool consistency averaged from baseline to day 28. All treatment groups, including placebo, showed significant improvements over time, yet differences between placebo and LX1033 in stool consistency were not statistically significant. Further analyses of the stool consistency data were performed adjusting for early terminations which may have enhanced the placebo response rate. These additional analyses of stool consistency yielded favorable results for the LX1033 500mg three times daily dose group compared to placebo, and some of these findings were associated with statistically significant results. LX1033 reduced the production of plasma 5-HIAA significantly more than placebo, with the greatest reductions observed in the 500 mg three times daily dose group. This same LX1033 dose also produced the greatest reduction in abdominal pain, an important measure of efficacy in IBS-d. The proportion of patients showing an abdominal pain intensity weekly response was 33% on placebo and 47% on LX1033 500 mg given three times daily. LX1033 was safe and well tolerated in the study, with adverse events evenly distributed among LX1033 treatment arms and placebo.
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April 16, 2014
07:55 EDTLXRXLexicon removed from Stifel Select List at Stifel
Stifel removed Lexicon from its Select List, citing what it sees as a lack of near-term data catalysts and limited visibility into a partnership for LX4211. The firm thinks the company is favorably positioned for a partnership, but that it's difficult to predict the timing of such a deal. It keeps a $4 price target and Buy rating on the shares.
April 14, 2014
08:59 EDTLXRXOn The Fly: Pre-market Movers
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06:25 EDTLXRXLexicon to host conference call
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06:10 EDTLXRXLexicon achieves positive results in Type 1 diabetes clinical trial
Lexicon Pharmaceuticals announced positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 that is designed to lower blood glucose levels through two insulin-independent mechanisms of action. In the placebo-controlled, double-blind, 28-day study, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo, while significantly improving glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group compared to a reduction of only 0.06% with placebo. This improvement was accompanied by significant improvement in the time spent in a glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia. Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication due to adverse events.
April 8, 2014
07:35 EDTLXRXNeedham to hold a conference
Life Sciences Conference is being held in New York on April 8-9.

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