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Lexicon Pharmaceuticals, Inc.
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Pablo Lapuerta, M.D., SVP of Clinical Development and CMO, gave guidance for data from the phase-II trial of Telotristant Etiprate in ulcerative colitis. He stated, "On slide 12 the Telotristat Etiprate we are in phase-II in ulcerative colitis. That proof of concept study is also looking at the safety profile of telotristat etiprate in these conditions. It’s targeting 60 patients with mild to moderate ulcerative colitis. We are getting close to the finish; we have over 50 patients in that study. So we will anticipate completion of enrollment in the second quarter and as previously discussed present top-line results in the third quarter of 2013."
Source: Q1 2013 earnings conference call, 5/10/13.
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Arthur T. Sands, M.D., Ph.D., President and CEO, gave guidance for data from the phase II PARSEC trial. He stated, "But our current view of this is that we should be seeing the results from Telotristat Etiprate in ulcerative colitis sometime at the end of the second quarter or first part of the third quarter."
Source: Q4 2012 earnings conference call, 2/21/13.
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Arthur T. Sands, M.D., Ph.D., President and CEO, gave guidance for data from the LX1033 IBSD and the Telotristat Etiprate ulcerative colitis programs. He stated, "Moving into 2013, LX1033 results in IBS, that is the trial that is also enrolling very well, somewhat ahead of schedule. That is a trial of our locally acting tryptophan hydroxylase inhibitor and 360 patients with IBSD, and then shortly thereafter, our results from Telotristat etiprate and ulcerative colitis."
Source: Q1 2012 earnings conference call, 5/02/12.
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Pablo Lapuerta, M.D., SVP of Clinical Development and CMO, commented on the progress being made with the phase II study of Telotristat etiprate (LX1032/LX1606). He stated, "We hope to have about 60 patients with mild-to-moderate ulcerative colitis, randomized to placebo on two different doses on Telotristat Etiprate to an 8-week study with efficacy measures that are common in ulcerative colitis studies. So, we initiated the study effectively. Enrollment is progressing. Randomization is a bit ahead of schedule."
Source: Q1 2012 earnings conference call, 5/02/12.
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Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis
Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01456052?term=lexicon+pharmaceutic...
| Compound/Device | Specialty | Indication | Compound Class | Target |
|---|---|---|---|---|
| Telotristat etiprate (LX1032/LX1606) Ulcerative colitis | Gastroenterology | Ulcerative colitis | Tryptophan hydroxylase inhibitor | Tryptophan hydroxylase |
Mechanism of action: Telotristat etiprate (LX1032/LX1606) is an orally-delivered small molecule under development as a potential treatment for the symptoms associated with ulcerative colitis. LX1032 acts by inhibiting the enzyme tryptophan hydroxylase (TPH). Animal models of ulcerative colitis have indicated a potential role for serotonin in the immunological response associated with inflammatory stimuli within the gastrointestinal tract.
Phase of Development: II
Event Type: Data: Phase II trial results
Dates: 2013-07-01 - 2013-09-30
Results: Pending