Lexicon Announces Presentation Of Manuscript At The American Diabetes Association Diabetes Care Symposium

THE WOODLANDS, Texas, June 6, 2015 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that the manuscript entitled "Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes" was presented today in Boston at the 75th Scientific Sessions of the American Diabetes Association (ADA) as part of the 4th Annual Diabetes Care Symposium by John B. Buse, M.D., Ph.D.  The manuscript was selected from over 150 manuscripts that were submitted and will be featured in a special July issue of Diabetes Care and is available for download online at care.diabetesjournals.org.

"The potential of this novel oral dual SGLT inhibitor to help patients with type 1 diabetes manage their condition is exciting news," commented Dr. Buse, Professor of Medicine and Chief of the Division of Endocrinology at the University of North Carolina, Chapel Hill. 

In a Phase 2 study, 33 patients with type 1 diabetes were treated with sotagliflozin, an oral dual SGLT1 and SGLT2 inhibitor, or placebo in a randomized, double-blind trial assessing safety, insulin dose, glycemic control, and other metabolic parameters over 29 days of treatment.  

After 29 days of therapy the sotagliflozin treated patients demonstrated reductions in A1C, body weight, and bolus, or mealtime insulin, and an increase in the time spent in target glucose range 70–180 mg/dL. There was no reduction in basal insulin. Change from baseline results are summarized below:

• A1C:  -0.55% sotagliflozin vs. -0.06% placebo (p=0.002)
• Number of Hypoglycemic Events/Patient/Day: -0.7 sotagliflozin vs. -0.4 placebo (not significant)
• Body Weight -1.7 kg sotagliflozin vs. +0.5 kg placebo (p=0.005)
• Bolus Insulin (primary endpoint):  -32% sotagliflozin vs. -6.4% placebo (p=0.007)
• Basal Insulin: -2.4% sotagliflozin vs. +0.2% placebo (not significant)

From a safety perspective, 14 (88%) patients on sotagliflozin reported adverse events compared with 12 (71%) patients on placebo.  No adverse events led to discontinuation from the study.  The most frequently reported treatment-emergent adverse events were gastrointestinal disorders, which were reported by eight sotagliflozin patients (50%) compared with three placebo patients (18%), with the most notable imbalance being three reports of nausea on sotagliflozin versus one on placebo.  Nausea generally occurred early, was mild in intensity and of short duration. Two serious adverse events of diabetic ketoacidosis (DKA) were reported in two patients using insulin infusion pumps and treated with sotagliflozin.  Both were assessed by the investigators as insulin pump-related, and not related to study drug.  Of note, both cases of DKA were of classic presentation, with blood glucose values above 350 mg/dL at the time of hospitalization.  Both patients fully recovered and resumed treatment with study drug.

About LexiconLexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease.  Lexicon has clinical-stage drug programs 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 StatementThis press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of sotagliflozin (LX4211), including characterizations of the results of and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin.  In addition, 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 meet its capital requirements, successfully conduct clinical development of sotagliflozin and preclinical and clinical development of its other potential drug candidates, 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, 2014, 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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SOURCE Lexicon Pharmaceuticals, Inc.