Lexicon Announces Positive Phase 2 Results of LX1031 in Non-Constipating Irritable Bowel Syndrome
- LX1031 demonstrates beneficial effect of new mechanism of action
- Clinical response correlates with reduction in biomarker of serotonin synthesis
- Favorable safety profile observed in patients treated during four-week study
Conference Call on November 13, 2009 at 11:00 a.m. Eastern Time
The Woodlands, Texas, November 12, 2009 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the company's investigational new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome (IBS). Top-line results showed that treatment with one gram of LX1031 four times daily produced a statistically significant improvement in global assessment of relief of IBS pain and discomfort over the four-week dosing period as compared to placebo (p=0.0465). Improvements in global assessment parameters also corresponded with statistically significant improvements in stool consistency. Notably, increased clinical response correlated with a greater reduction in serotonin synthesis as reflected by measures of urinary 5-HIAA, a breakdown product of serotonin.
"Treatment with LX1031 reduced symptoms of IBS in this clinical trial, and holds promise for patients with this disease," said Dr. Brian Zambrowicz, chief scientific officer at Lexicon. "We believe the fact that the clinical benefit was correlated to the reduction in the 5-HIAA biomarker validates our therapeutic strategy of inhibiting TPH as a novel treatment option for patients with IBS. The overall safety and efficacy profile observed to date supports further development of this novel mechanism in IBS."
The Phase 2 clinical trial, which began at the end of December 2008, was a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with IBS. The study included 155 patients with either diarrhea-predominant IBS or mixed IBS. Two dose levels were evaluated: a 250 mg dose and a 1,000 mg dose, each administered four times daily (QID). LX1031 was well tolerated, with no statistically significant differences in adverse events observed between placebo and either treatment group. Efficacy endpoints evaluated included a global assessment of adequate relief, as well as measures of specific symptoms associated with IBS. Based on the positive data obtained, Lexicon intends to pursue the development of LX1031 as a novel treatment for patients with IBS.
"We are pleased with the outcome of this proof-of-concept trial as we continue to advance our pipeline of drug candidates with new mechanisms of action," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. "These results further validate our genetic strategy to discover breakthrough treatments for human disease."
Top-line results from this study will be presented at the upcoming GASTRO 2009 conference in London on November 25, 2009 at 2:30 pm local time, included in the session entitled, "Therapeutic insights in functional digestive disorders."
Lexicon has three additional drug candidates progressing through Phase 2 clinical trials including LX1032, a peripherally-available TPH inhibitor for carcinoid syndrome, LX2931, an S1P lyase inhibitor for rheumatoid arthritis, and LX4211, an SGLT2 inhibitor for type 2 diabetes. Phase 2 clinical results from these programs are expected over the next 12 months.
Lexicon Conference Call
Lexicon management will hold a conference call to discuss the LX1031 results at 11:00 a.m. Eastern Time on November 13, 2009. The dial-in number for the conference call is 888-220-1244 (within the US/Canada) or 706-679-5615 (international). The conference ID for all callers is 41598440. An archived version of the call will be available on Lexicon's corporate website at www.lexpharma.com.
LX1031 was discovered and developed by Lexicon as an oral drug candidate for IBS following Lexicon's identification of the TPH target as a key control point for the regulation of peripheral serotonin production. LX1031 is designed to treat symptoms associated with IBS by selectively decreasing the production of serotonin in the GI tract. In Phase 1 clinical trials, all dose levels were well tolerated, with no dose-limiting toxicities observed, and LX1031 was shown to reduce levels of urinary 5-HIAA, a biomarker of serotonin production.
LX1031 is being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.
About Irritable Bowel Syndrome
Irritable bowel syndrome is a disorder most commonly characterized by cramping, abdominal pain, bloating, constipation or diarrhea. According to the International Foundation for Functional Gastrointestinal Disorders, IBS affects between 25 and 45 million people in the United States. Symptoms of IBS are believed to be mediated through serotonin, which has been shown to play an important role in modulating motility and signaling feelings of GI discomfort.
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company's research team. The company has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's plans for further clinical development of LX1031, characterization of the results of the Phase 2 clinical trial of LX1031, the safety and efficacy profile of LX1031 observed in clinical trials supporting further development for IBS, the validity of Lexicon's therapeutic strategy of inhibiting TPH, the validity of Lexicon' s genetic strategy to discover breakthrough treatments for human disease, and the potential therapeutic and commercial potential of LX1031. This press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products other than LX1031, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to the clinical development of LX1031 and preclinical and clinical development of Lexicon's other potential drug candidates and Lexicon's ability to successfully advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2008, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise