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Lexicon Pharmaceuticals, Inc.

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The Woodlands, Texas, July 30, 2013 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three and six months ended June 30, 2013.

“We have continued to advance multiple programs in our clinical pipeline, most notably completing enrollment of Phase 2 studies of telotristat etiprate in ulcerative colitis and LX1033 in diarrhea-predominant irritable bowel syndrome. We look forward to obtaining top-line results from these studies around the end of the third quarter and in the fourth quarter of 2013, respectively,” said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. “In addition, we obtained initial safety data from the pioneer portion of our Phase 2 trial of LX4211 in Type 1 diabetes and subsequently advanced the study into its expansion phase.”
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Source: press release, 7/30/13. http://www.lexgen.com/news/press-releases/2290-lexicon-pharmaceuticals-p...

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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/DeviceSpecialtyIndicationCompound ClassTarget
Telotristat etiprate (LX1032/LX1606) Ulcerative colitisGastroenterologyUlcerative colitisTryptophan hydroxylase inhibitorTryptophan 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:

Lexicon Completes Pilot Study of Telotristat Etiprate in Ulcerative Colitis

The Woodlands, Texas, October 9, 2013 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced top-line results from a pilot study exploring the use of telotristat etiprate in ulcerative colitis. Telotristat etiprate, a serotonin synthesis inhibitor, is currently in Phase 3 development for carcinoid syndrome, a condition caused by metastatic, functioning neuroendocrine tumors. Elevated serotonin is a hallmark of carcinoid syndrome, and two previous Phase 2 clinical trials have shown that clinical benefits of telotristat etiprate treatment were associated with significant reductions in 5-HIAA, a biomarker of serotonin production. Genetic and pharmacological studies in preclinical models had also suggested that reducing serotonin levels might benefit patients with other forms of gastrointestinal disease such as ulcerative colitis.

In this pilot study of mild to moderate ulcerative colitis, telotristat etiprate achieved the primary objective of demonstrating safety and tolerability. Adverse events and discontinuations were evenly distributed between treatment and placebo and there were no serious adverse events attributed to the investigational drug. In addition, telotristat etiprate showed dose-dependent, statistically significant reductions in 5-HIAA from baseline compared to placebo (p < 0.001), with a relationship between the biomarker and certain measures of clinical benefit being observed in the high dose group. Although these results provide a clear signal of activity of the mechanism of action of telotristat etiprate in this patient population, they were not accompanied by other findings that would indicate a large impact on disease modification.

“The top-line results clearly support a favorable safety profile of telotristat etiprate and, importantly, will contribute to our overall safety database for this investigational, orphan drug,” said Pablo Lapuerta, M.D., Lexicon’s chief medical officer. “The reductions in serotonin biosynthesis in this study are consistent with beneficial gastrointestinal effects we have observed in other settings; however, the results from this limited trial do not provide compelling evidence of an effect on the underlying pathogenesis of ulcerative colitis, a standard we require to move forward in this indication. We plan, therefore, to maintain the focus of Lexicon resources on the ongoing Phase 3 program in carcinoid syndrome as the primary indication for telotristat etiprate.”

In this multicenter study, 59 patients with mild-moderate ulcerative colitis were randomized to placebo, a 500 mg dose of investigational drug telotristat etiprate taken orally once daily, or a 500 mg dose of telotristat etiprate three times daily. Treatment was given for 8 weeks. In the context of a pilot study, additional analyses will be conducted to best understand the clinical significance of the results, which are planned for presentation at a scientific congress in 2014.
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Source: press release, 10/09/13. http://www.lexgen.com/news/press-releases/2299-lexicon-completes-pilot-s...