Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes Trial to Test Oral Therapy for Insulin-Dependent Diabetes
THE WOODLANDS, Texas, May 3, 2012 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that an independent, non-profit organization will provide funding to support the Phase 2 development of LX4211 in type 1 diabetes.
LX4211, a dual inhibitor of sodium glucose transporter 1 and 2 (SGLT1 and SGLT2), was designed to improve control of blood glucose through mechanisms that do not require the pancreas to produce insulin. In type 1 diabetes, also called juvenile diabetes, the pancreas stops producing enough insulin to support life. People with type 1 diabetes must monitor their blood sugar levels through frequent measures of blood glucose in order to select and administer doses of insulin via shots or an insulin pump, multiple times every day. With current insulin therapies, even vigilant management of blood sugar does not eliminate the risk of type 1 diabetes complications such as heart attack, stroke, blindness, and kidney failure.
"Results we have obtained to date with LX4211 encourage us to expand its potential application to both type 1 and type 2 diabetes, a unique opportunity for an oral therapy," said Arthur T. Sands, M.D., Ph.D., Lexicon's president and chief executive officer. "In this new trial, we hope to see significant reductions in the amount of insulin required by type 1 patients as well as more consistent blood sugar control."
LX4211 has already demonstrated beneficial effects on glucose control in clinical trials conducted to date in type 2 diabetes, or adult-onset diabetes. Studies have shown that LX4211 lowers blood sugar levels after meals, reducing glucose absorption from the gastrointestinal tract and triggering the production of beneficial hormones such as glucagon-like peptide-1 (GLP-1) that help regulate blood glucose levels. In addition, LX4211 enhances excretion of glucose in the urine, which may also help to reduce the need for insulin, without causing low blood sugar or hypoglycemia. Lexicon expects to have results from an ongoing Phase 2b trial in type 2 diabetes by mid-year 2012.
About the Clinical Trial in Type 1 Diabetes
The initial Phase 2 proof-of-concept study will be a randomized, double-blinded, placebo-controlled trial in approximately 25 adult patients with type 1 diabetes who will receive LX4211 over a one month treatment period. The primary endpoint of the study will be reduction of insulin required with LX4211 as compared to placebo. Secondary endpoints will include multiple measures of blood sugar to show that LX4211 helps to maintain glycemic control during the treatment period. Under the agreement, additional funding could support future Phase 2 trials of LX4211 in type 1 diabetes.
About Type 1 Diabetes
An estimated 1.3 million people in the U.S. have type 1 diabetes, a chronic disease usually caused by autoimmune destruction of insulin-producing beta cells of the pancreas. The resulting decrease in insulin leads to high levels of glucose in the blood, which in turn can lead to acute metabolic complications as well as chronic problems with eyes, kidneys, nervous system and heart. If not properly controlled with insulin therapy, type 1 diabetes can be fatal. Patients with type 1 diabetes are at least 10 times more at risk for cardiovascular disease compared to people without diabetes. The rate of type 1 diabetes incidence among children under the age of 14 is estimated to increase by 3% annually worldwide.
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has five drug programs in mid-stage development for diabetes, carcinoid syndrome, irritable bowel syndrome, rheumatoid arthritis and glaucoma, 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, including characterizations of the results of and projected timing of clinical trials of such compounds, and the potential therapeutic and commercial potential of LX4211. 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. Unless specifically indicated otherwise, results reported as trends were not statistically significant. 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, 2011, 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.