Navigation Links
Lexicon Completes Phase 2 Study Of LX1033 In IBS-d

THE WOODLANDS, Texas, Dec. 3, 2013 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced top-line results from an initial Phase 2 study exploring the use of LX1033 in diarrhea-predominant irritable bowel syndrome (IBS-d). LX1033 is an investigational drug that inhibits 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.

The primary endpoint of this study was the change in stool consistency averaged from baseline to day 28. All treatment groups, including placebo, showed significant improvements over time, yet differences between placebo and LX1033 in stool consistency were not statistically significant. Further analyses of the stool consistency data were performed adjusting for early terminations which may have enhanced the placebo response rate. These additional analyses of stool consistency yielded favorable results for the LX1033 500mg three times daily dose group compared to placebo, and some of these findings were associated with statistically significant results (p<0.05). LX1033 reduced the production of plasma 5-HIAA (a biomarker for serotonin synthesis) significantly more than placebo, with the greatest reductions observed in the 500 mg three times daily dose group. This same LX1033 dose also produced the greatest reduction in abdominal pain, an important measure of efficacy in IBS-d. The proportion of patients showing an abdominal pain intensity weekly response (defined as a reduction in abdominal pain of at least 30% from baseline for at least 50% of the weeks assessed, with no worsening from baseline in stool consistency) was 33% on placebo and 47% on LX1033 500 mg given three times daily (p<0.05). LX1033 was safe and well tolerated in the study, with adverse events evenly distributed among LX1033 treatment arms and placebo.

"While LX1033 showed similar improvements in stool consistency as compared to the placebo patients who completed the study, there were positive effects on abdominal pain in the treated group that warrant further study," said Pablo Lapuerta, M.D., Lexicon's chief medical officer. "While this initial Phase 2a study was underway, we completed long-term toxicology studies which would allow us to conduct a Phase 2b study at doses informed by the current results and with a duration of 12 weeks, a treatment period that has historically been important to identify clinically meaningful changes as compared to placebo."

In this Phase 2 study of IBS-d, 373 patients were randomized to be treated for 28 days with either placebo or one of three different dose levels of LX1033 for 28 days, 1000 mg twice daily, 500 mg twice daily, and 500 mg three times daily. The primary endpoint was the change from baseline in stool consistency as evaluated by the Bristol Stool Form Scale. A key secondary endpoint was the change from baseline in abdominal pain, and other endpoints included the change in plasma 5-HIAA.

About Lexicon
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease.  Lexicon currently has multiple programs in clinical development for diabetes, irritable bowel syndrome, carcinoid syndrome and other indications, all of which were discovered by Lexicon's research team.  Lexicon 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

Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX1033, characterizations of the results of and projected timing of clinical trials of LX1033, and the potential therapeutic and commercial potential of LX1033.  The press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, 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 Lexicon's ability to successfully conduct clinical development of LX1033 and preclinical and clinical development of its other potential drug candidates, 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 "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2012, 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.

SOURCE Lexicon Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Lexicon to Provide First Quarter 2012 Financial Results
2. Lexicon Pharmaceuticals Reports On Clinical Program Status And 2012 First Quarter Results
3. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
4. Lexicon Pharmaceuticals to present at the Jefferies 2012 Global Healthcare Conference
5. Lexicon Presents Data Regarding the Mechanism of Action and Safety of LX4211 at American Diabetes Association Meeting
6. Lexicon Announces Positive Results of LX4211 Phase 2b Trial For Type 2 Diabetes
7. Lexicon Announces Publication of Results of Two Studies of LX4211 in Patients with Type 2 Diabetes in the Journal Clinical Pharmacology & Therapeutics
8. Lexicon to Provide Second Quarter 2012 Financial Results
9. Lexicon Pharmaceuticals Reports On Clinical Program Status And 2012 Second Quarter Results
10. Lexicon Pharmaceuticals To Present At The Wedbush PacGrow 2012 Management Access Conference
11. Lexicon Pharmaceuticals Reports Preliminary Results From Two Phase 1 Studies
Post Your Comments:
(Date:11/26/2015)... Carolina , 26 november 2015 /PRNewswire/ ... (AAIPharma/CML) kondigt de geplande investering aan van ... van de laboratoria en het mondiale hoofdkantoor ... De uitbreiding zal resulteren in extra kantoorruimte ... voldaan aan de groeiende behoeften van de ...
(Date:11/26/2015)... SAN FRANCISCO , November 26, 2015 ... 1.82 billion by 2022, according to a new report by ... as Chronic Kidney Disease (CKD) which demands kidney transplantation is ... convenient and cost effective substitute for organ transplantation. --> ... 1.82 billion by 2022, according to a new report by ...
(Date:11/26/2015)... , November 26, 2015 ... Juntendo universitetssjukhus ser potential att använda ... magnetresonansbilder (MR-bilder) för patienter med multipel ... ett forskningsavtal med SyntheticMR AB för att ... forskningsprojekt på sjukhuset. Med SyMRI kan man ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... 2015 , ... Somu Sivaramakrishnan announced today that he joined ... offers travelers, value and care based Travel Services, including exclusive pricing on a ... cabin upgrades and special amenities such as, shore excursions, discounted fares, travel gifts ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... Jobs in ... by healthcare professionals and offered by healthcare staffing agency Aureus Medical Group . ... the month of October 2015 among those searching for healthcare jobs through the company’s ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... process, participated in the 61st annual Employee Benefits Conference. The Employee Benefits Conference ... Sunday, November 8th through Wednesday, November 11th, 2015. The conference was held at ...
(Date:11/26/2015)... Karnataka (PRWEB) , ... November ... ... innovative online platform for mental health and wellness consultation, has collaborated with ... to holistically address their reader’s queries on topics on mental and emotional ...
(Date:11/25/2015)... ... November 25, 2015 , ... Additional ... those found on mammography, according to a study published online in the journal ... seen on mammography may necessitate a change in treatment. , Breast MRI is ...
Breaking Medicine News(10 mins):