THE WOODLANDS, Texas, July 9, 2014 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that JDRF, the world's largest non-profit supporter of type 1 diabetes (T1D) research, will provide funding to support a Phase 2, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of LX4211 in a younger population with T1D. Up to 76 individuals with T1D, younger than 30 years of age and with HbA1c levels greater than 9.0%, are expected to be randomly assigned to receive either placebo or a once daily 400mg dose of LX4211 and complete the 12-week treatment period. The primary objective of this study is to demonstrate the superiority of LX4211 versus placebo as adjunct to insulin treatment on HbA1c reduction at 12 weeks as well as several secondary endpoints, including reduced variability in blood glucose levels and lower insulin needs.
"JDRF has a strategic T1D research plan designed to deliver a sustained stream of new life-changing therapies, so we are pleased to collaborate with Lexicon on the development of LX4211 in T1D," said Sanjoy Dutta, Ph.D., JDRF's assistant vice president, translational development. "This collaboration is part of JDRF's Glucose Control Research Program whose goal is to develop and deliver improved insulin and non-insulin adjunct therapies that progressively improve glucose and overall metabolic control in individuals with T1D. We believe that LX4211's dual SGLT1/SGLT2 inhibitory mechanism offers an innovative and exciting opportunity to deliver on this goal and address an important unmet medical need in those with T1D struggling to achieve optimal glucose control target levels."
"The results from our previous Phase 2 study of LX4211 in type 1 diabetes have encouraged us to also explore its potential application in this younger population for whom managing glucose variability is an especially difficult challenge and in which the significant majority are unable to achieve HbA1c targets," said Pablo Lapuerta, M.D., Lexicon's executive vice president and chief medical officer. "Importantly, we hope to continue to see improvement in glycemic control with a longer treatment period combined with reductions in the amount of insulin required and related improvements in quality of life in this population of high unmet medical need. This study complements our ongoing preparations for Phase 3 in type 1 diabetes, which are proceeding, as well as our plans for LX4211 in type 2 diabetes."
LX4211 is 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. In a previous Phase 2 clinical trial of LX4211 in type 1 diabetes, LX4211 treatment was shown to reduce mean HbA1c by 0.55% compared to a reduction of only 0.06% with placebo (p=0.002) over a four-week treatment period. At the same time, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo (p=0.007), while reducing variability in blood glucose levels. These improvements were accompanied by significantly more time spent in the target glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia.
About Type 1 Diabetes
Type 1 diabetes is a serious condition affecting more than one million people in the United States, both children and adults. Type 1 diabetes is an autoimmune disease in which a person's pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body's immune system attacks and destroys the insulin-producing cells in the pancreas. Insulin is a required treatment, with few additional treatment options. The effectiveness of insulin is limited by concerns about potentially serious hypoglycemia; therefore, most patients with type 1 diabetes do not achieve their targets for glucose control. In addition, insulin therapy does not necessarily prevent the possibility of the disease's serious complications, which may include kidney failure, blindness, nerve damage, heart attack and stroke. As an oral agent, LX4211 is designed to delay the absorption of glucose in the gastrointestinal tract and enhance glucose excretion in the kidney, allowing glucose control to improve and insulin doses to be reduced.
Lexicon 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.
JDRF is the leading global organization funding type 1 diabetes (T1D) research. JDRF's goal is to progressively remove the impact of T1D from people's lives until we achieve a world without T1D. JDRF collaborates with a wide spectrum of partners and is the only organization with the scientific resources, regulatory influence, and a working plan to better treat, prevent, and eventually cure T1D. As the largest charitable supporter of T1D research, JDRF is currently sponsoring $568 million in scientific research in 17 countries. For additional information about JDRF, please visit www.jdrf.org.
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 of LX4211, and the potential therapeutic and commercial potential of LX4211. The 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 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 "Risk Factors" in Lexicon's annual report on Form 10-K for the year endedDecember 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.