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Lexicon's Irritable Bowel Syndrome Drug LX1031 Shows Positive Results In Phase II Trials, Shares Climb - Update
11/12/2009 7:31 PM  ET
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Lexicon Pharma Reports Positive Mid-stage Trial Results Of LX1031 In Non-Constipating Irritable Bowel Syndrome
Lexicon Announces Positive Phase 2 Results Of LX1031 In Non-Constipating Irritable Bowel Syndrome - Quick Facts

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(RTTNews) -  Developmental stage pharma company Lexicon Pharmaceuticals, Inc. (LXRX: News ), Thursday reported positive Phase II results evaluating LX1031, the company's investigational new drug for non-constipating Irritable Bowel Syndrome or IBS, sending shares up 18% in after-hours trading.

The four-week long Phase II trails that began in December last year, tried to establish the safety, tolerability and efficiency of two dosages, 250 mg and 1000 mg of LX1031 in reducing symptoms of the disease, among 155 patients, with either diarrhea-predominant IBS or mixed IBS.

According to results, patients reported significant relief from IBS pain and discomfort over the four-week period, when treated with one gram of LX1031 four times daily, compared with placebo. Stool consistency also improved on using the drug, noted the company.

Commenting on the positive data obtained, Woodlands, Texas-based Lexicon said, "the fact that the clinical benefit was correlated to the reduction in the 5-HIAA bio marker validates our therapeutic strategy of inhibiting TPH as a novel treatment option for patients with IBS. The overall safety and efficacy profile observed to date supports further development of this novel mechanism in IBS."

The oral investigational drug works by inhibiting TPH or Tryptophan Hydroxylase, an enzyme critical in the production of a neuro-transmitter serotonin. About 80% to 90% of the human body's total serotonin is located in the enterochromaffin cells in the gut, where it is used to regulate intestinal movements.
Irritable bowel syndrome is commonly characterized by cramping, abdominal pain, bloating, constipation or diarrhea. According to the International Foundation for Functional Gastrointestinal Disorders, IBS affects between 25 and 45 million people in the United States

The company also has three additional drug candidates progressing through Phase 2 clinical trials including LX1032 for carcinoid syndrome, LX2931 for rheumatoid arthritis and LX4211 for type 2 diabetes. The Mid-stage results are expected to be out in the next twelve months.

LXRX last traded at $1.39, down 10 cents or 6.71% on the Nasdaq. In after-hours trading, shares climbed 17.99% to $1.64.

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