Lexicon Pharmaceuticals (LXRX) announced the latest in a string of disappointments for its development pipeline, but management remains upbeat.
On December 3, 2013, the company announced that a Phase II study of LX-1033 in IBS-D (diarrhea-prominent irritable bowel syndrome) failed to meet its primary endpoint.
LX-1033 targets serotonin synthesis in the gastrointestinal tract. Serotonin is a neurotransmitter that has been shown to play a role in the symptoms of irritable bowel syndrome. This study enrolled 373 patients for 28 days with three treatment groups and one placebo group. According to management, all groups showed significant improvement in stool consistency (the primary endpoint) over that time; however the improvement between the groups was not statistically significant. The company discussed a post-hoc data analysis that adjusted for early terminations in the study suggesting that at a dose of 500mg three times a day, the product showed improvement in pain and stool consistency compared with placebo. However, the company did not show detailed data to support its conclusions.
Management indicated that it may do another study of LX-1033 on the ad-hoc analysis, based largely what it believes is a meaningful reduction in abdominal pain as well as the possibility that thrice-daily dosing may have a meaningful improvement on stool consistency.
More important for Lexicon is LX-4211, a SGLT 1/-2 inhibitor for diabetes. LX-4211 is the first dual inhibitor of SGLT1 and SGLT2 in clinical development for diabetes. LX4211 has completed a Phase 2b trial in patients with type 2 diabetes, and initiation of Phase 3 studies is anticipated for the second half of 2013. The question is whether the $150 million of cash on the balance sheet (as of September 30, 2013) is sufficient to fund the necessary phase 3 studies.
