THE WOODLANDS, Texas, June 21 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, presented clinical data and analysis from its Phase 2a clinical trial of LX4211 for patients with type 2 diabetes mellitus at ENDO 2010 today. The results reported today included newly-obtained data showing a trend of increased total GLP-1 in both LX4211 treatment arms relative to placebo as measured in a post-trial analysis of blood samples.
The Phase 2a clinical trial demonstrated that administration of LX4211, a dual SGLT2 and SGLT1 inhibitor, produced rapid and significant improvement in multiple assessments of glycemic control as well as positive trends in cardiovascular and metabolic parameters after only 28 days of dosing in type 2 diabetes patients. Importantly, after only four weeks of dosing, average percent hemoglobin A1c (HbA1c), a measure of blood glucose levels over time, was significantly reduced by 1.15 in the 150 mg dose group (p=0.036) and by 1.25 in the 300 mg dose group (p=0.017), as compared with 0.49 in the placebo group. HbA1c levels were reduced to less than or equal to 7% for half the patients in both dose groups; baseline levels were 8.22%, 8.50% and 8.20% for the 150 mg, 300 mg and placebo groups, respectively. In addition, positive trends were observed in weight, blood pressure and triglyceride reduction.
"The increases observed in total GLP-1 levels among type 2 diabetes patients randomized to LX4211 are consistent with what might be expected from SGLT1 inhibition in the small intestine stimulating the endogenous incretin pathway," commented Brian Zambrowicz, Ph.D., Lexicon's executive vice president and chief scientific officer. "We believe the unique-in-class SGLT1 activity synergizes with SGLT2 inhibition to produce the rapid and robust glycemic control observed with this compound in our Phase 2a study."
LX4211 is an orally-delivered small molecule under development as a potential treatment for diabetes. LX4211 inhibits both sodium-glucose cotransporter type 2, or SGLT2, and sodium-glucose cotransporter type 1, or SGLT1. SGLT2 is a transporter responsible for most of the glucose reabsorption performed by the kidney. SGLT1 is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney. For more information on LX4211, and to access the oral presentation and poster please visit www.lexpharma.com.
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has four drug candidates in mid-stage development for diabetes, irritable bowel syndrome, carcinoid syndrome and rheumatoid arthritis, 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 www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to the characterization of the safety and efficacy profile of LX4211 observed in the Phase 2 clinical trial as positive or favorable, the characterization of the results of the Phase 2 clinical trial of LX4211 as demonstrating the potential for a therapeutic benefit for patients with type 2 diabetes, the mechanism of action of LX4211, and the potential therapeutic and commercial potential of LX4211 generally. This 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 LX4211 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 "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2009, 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.