Lexicon Pharmaceuticals, Inc. (LXRX), a biopharmaceutical company focused on developing breakthrough treatments for a variety of human diseases, recently announced that it successfully completed a second Phase 1 clinical trial of LX1032. The drug candidate will be used by patients to manage gastrointestinal symptoms associated with carcinoid syndrome, which is a chronic condition that results in metastatic neuroendocrine tumors that secrete large amounts of serotonin.
During the Phase 1b multiple ascending-dose trial, the LX1032 was found to be well-tolerated at all dosage levels by all 40 volunteers. Five doses were given to the participants ranging from 100 mg to a maximum dosage of 1500 mg over a 14-day period. Analysis of the data found that LX1032 significantly reduced blood serotonin levels and urinary 5-HIAA, a market of serotonin biosynthesis. No serious adverse effects were reported by the volunteers of the trial.
“The substantial reduction in serotonin observed in this study confirms our preclinical observations and suggests potent inhibition of peripheral serotonin production,” said Philip Brown, Senior Vice President at Lexicon. “We are eager to test the compound in patients with carcinoid syndrome who suffer from significant gastrointestinal symptoms relating to the overproduction of serotonin.”
Lexicon has plans to move forward and initiate a Phase 2 study focusing on patients with carcinoid syndrome. In June 2008, the FDA gave LX1032 a Fast Track designation that facilitates the development of the drug and expedites the review of the drug. LX1032 will be the third drug candidate developed by Lexicon that has successfully moved into Phase 2 clinical trials.
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