The Woodlands, Texas, May 10, 2013 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it is progressing into the placebo-controlled portion of its Phase 2 clinical trial of LX4211 in patients with type 1 diabetes, having successfully completed the open-label, pioneer portion of the trial. LX4211 is an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2).
The pioneer phase of the study was designed to gain important initial information regarding the safety of co-administration of LX4211 with insulin in this, the first test of dual inhibition of SGLT1 and SGLT2 in patients with insulin-dependent type 1 diabetes. The successful conclusion of the 28-day pioneer group enables the initiation of the placebo-controlled expansion phase of the study to commence in up to 30 patients with type 1 diabetes. Based on the results observed in the pioneer group, Lexicon has identified the 400 mg once daily dose of LX4211 as the appropriate treatment for the expansion phase of the trial.
"This is a very important first step in the future development of LX4211 in type 1 diabetes," said Dr. Arthur Sands, president and chief executive officer of Lexicon. "The preliminary results are very encouraging and provide a strong rationale for moving into the expansion phase of the trial."
LX4211, a first-in-class dual inhibitor, reduces the amount of glucose that enters the bloodstream from the gastrointestinal (GI) tract by inhibiting SGLT1, the major transporter responsible for glucose absorption, and enhances glucose excretion in the urine by inhibiting SGLT2, the major transporter responsible for glucose reabsorption by the kidney. Lexicon has previously demonstrated that SGLT1 inhibition by LX4211 increases GLP-1 and PYY, GI hormones associated with glycemic control and appetite. Lexicon is also developing LX4211 for type 2 diabetes with Phase 3 planning ongoing.
About Type 1 Diabetes
It is estimated that every year in the United States, more than 15,000 young people under the age of 20 years are diagnosed with type 1 diabetes mellitus. Type 1 diabetes is a disease caused by an autoimmune destruction of the insulin-producing beta-cells in the pancreas, resulting in an absolute insulin deficiency. Maintaining glycemic control is a key therapeutic goal in order to delay or prevent the complications of diabetes including retinopathy, nephropathy, neuropathy and macrovascular disease. Insulin use to maintain tight glycemic control presents significant challenges for patients, both logistically and medically, with constant approximations and adjustments made to accommodate various meals and activity levels. Despite advances in insulin therapy (fast-acting mealtime analogs, long-acting basal analogs, and insulin pump therapy) and glycemic monitoring (continuous glucose monitoring), tight glycemic control is still associated with hypoglycemia. A new therapy used in combination with insulin that offers the advantages of improved glycemic control, reduced and simpler insulin regimen, and lower incidence of hypoglycemia would offer a significant advancement in therapy for this serious chronic disease which still results in excess morbidity and mortality.
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 www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX4211, characterizations of the results of and projected timing of clinical trials, and the potential therapeutic and commercial potential of LX4211. This press release also contains forward-looking statements regarding 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, 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.