November 14, 2008
Lexicon Pharmaceuticals Completes Phase I Carcinoid Syndrome Trial
Lexicon Pharmaceuticals, a biopharmaceutical company, has successfully completed a second Phase I clinical trial of LX1032, an orally-delivered small molecule drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome.
Based on the results from this study, Lexicon is planning to initiate a Phase II study in patients with carcinoid syndrome. LX1032 will be Lexicon's third drug candidate to progress to Phase II clinical trials.
Clinical development of LX1032 is being funded through product development collaboration with Symphony Capital Partners and its co-investors.
In the recently-completed Phase Ib multiple ascending-dose trial, LX1032 was well tolerated at all doses, including the maximum daily dose of 1,500mg over the 14-day dosing period. Results from this trial demonstrated a potent reduction in both blood serotonin levels and urinary 5-HIAA, a marker of serotonin biosynthesis, at doses from 500mg to the maximum dose of 1,500mg, indicating that the target of LX1032 represents a new mechanism for regulating peripheral serotonin synthesis.
Philip Brown, senior vice president of clinical development of Lexicon, said: "The substantial reduction in serotonin observed in this study confirms our preclinical observations and suggests potent inhibition of peripheral serotonin production. We are eager to test the compound in patients with carcinoid syndrome who suffer from significant gastrointestinal symptoms relating to the overproduction of serotonin."