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SOURCE Lexicon Pharmaceuticals, Inc.
Results from Clinical Study in Type 2 Diabetes Patients with Renal Impairment and Preclinical Study in Type 1 Diabetes
THE WOODLANDS, Texas, June 14, 2014 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), presented data at the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco on LX4211, an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) that is designed to lower blood glucose levels through two insulin-independent mechanisms of action. Results presented from a clinical study showed that LX4211 significantly reduced postprandial glucose levels in type 2 diabetes patients with moderate to severe renal impairment.
In a double-blind, randomized, placebo-controlled, parallel-group study with 31 patients, LX4211 provided statistically significant reductions (p=0.003) in postprandial glucose in type 2 diabetes patients with moderate to severe renal impairment. In a sub-group analysis of patients with the most advanced renal impairment, defined as those with a glomerular filtration rate (GFR) of less than 45 ml/min/1.73 m2, LX4211 similarly reduced postprandial glucose as compared to placebo (p=0.002). Exhibiting its inhibition of SGLT1, LX4211 produced significant elevations in both total GLP-1 (p=0.017) and active GLP-1 (p=0.042) across all patients. There were no serious adverse events and no discontinuations due to adverse events during the study.
In an additional presentation at ADA, Lexicon presented data showing that LX4211 improved glycemic control in mice with poorly controlled type 1 diabetes. LX4211 significantly lowered blood glucose levels in both the low dose (2 mg/kg LX4211) and high dose (30 mg/kg LX4211) groups while reducing the occurrences of hypoglycemia. In addition, LX4211 significantly slowed the rise in HbA1c levels as compared to vehicle-treated mice with poorly controlled type 1 diabetes.
Complete presentations of the data are available for download from Lexicon's corporate website www.lexpharma.com.
Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease. Lexicon currently has drug programs in clinical development for diabetes, 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. 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 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 preclinical and clinical development of its 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, 2013, 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.
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