Lexicon Pharmaceuticals has successfully completed a Phase I clinical trial of LX1033, an orally-delivered small molecule drug candidate for the treatment of diarrhoea-predominant irritable bowel syndrome.
LX1033 is designed to act locally in the gastrointestinal tract by reducing the serotonin available for receptor activation without affecting serotonin levels in the brain.
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Study endpoints included safety and tolerability together with pharmacokinetic and pharmacodynamic parameters consisting of measures of both plasma and urinary 5-hydroxyindoleacetic acid biomarker.
The randomised, placebo-controlled trial, which involved eight healthy volunteers, showed that LX1033 was safe and well tolerated at all doses and produced a significant reduction in serotonin synthesis compared to placebo, as measured by both plasma and urinary 5-hydroxyindoleacetic acid.
Lexicon now plans to move LX1033 forward in to a Phase II study in patients with diarrhoea-predominant irritable bowel syndrome.
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