Lexicon Pharmaceuticals has reported positive, topline results from a Phase II study of LX1032 (telotristat etiprate) in carcinoid syndrome.
LX1032 is designed to reduce serotonin production that is associated with the condition.
The randomised, double-blind and placebo-controlled study involved 23 patients with carcinoid syndrome who received either placebo or one of four doses of the drug daily for 28 days.
In the study, efficacy measures included change in bowel movement frequency, relief of symptoms and reduction in serotonin synthesis.
The data showed that patients given LX1032 achieved reductions of at least 30% in the number of bowel movements per day for two weeks or more, relief of carcinoid symptoms and reduction of at least 50% in urinary 5-HIAA, a biomarker of serotonin synthesis.
It was observed that the drug was safe and well tolerated with mild to moderate adverse events.
Lexicon president and CEO Arthur Sands said that, based on the positive results of the US study, as well as encouraging observations from the clinical trial in Europe, they intend to discuss a Phase III development plan for carcinoid syndrome with the US Food and Drug Administration.
