6/25/2012 8:37:03 AM
THE WOODLANDS, Texas, June 25, 2012 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today that LX4211, an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c (HbA1c) in a Phase 2b trial in patients diagnosed with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy. LX4211 treatment also produced significant reductions in body weight and blood pressure. Importantly, LX4211 treatment had a favorable safety profile and was well tolerated in the study.
LX4211, a unique 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.
"New diabetes therapies will need to help patients safely control blood sugar and address other metabolic parameters that play a role in this pervasive disease," said Dr. Arthur Sands, president and chief executive officer of Lexicon. "The positive results obtained when LX4211 is combined with metformin suggest it has the potential to make a meaningful contribution to diabetes care."
In this 12-week dose-ranging study conducted in over 50 centers in the United States, 299 patients with poorly controlled type 2 diabetes on metformin therapy were randomized to receive either LX4211 or placebo. The primary endpoint of the study was the change in HbA1C, a measure of glycemic control, from baseline to week 12. LX4211 was administered at doses of 75 mg QD, 200 mg QD, 200 mg BID and 400 mg QD. Top-line results showed that patients in the LX4211 treatment arms had mean HbA1C reductions from baseline of 0.43, 0.52, 0.79 and 0.95 percent, respectively (p<0.001 for all treatment arms). In patients randomized to placebo, HbA1C decreased by 0.09 percent.
Adverse events were generally mild to moderate, and the overall incidence of adverse events with LX4211 was similar to placebo. There were four serious adverse events, none attributed to treatment, which were equally distributed across treatment groups and placebo. Importantly, there were no hypoglycemic events reported.
"We believe the encouraging results obtained from this study further differentiate LX4211 from the SGLT2-selective inhibitors currently in development," said Dr. Brian Zambrowicz, Lexicon's chief scientific officer. "The enhanced glycemic control and favorable safety profile observed in this study are characteristics we believe are related to LX4211's dual mechanism of action."
"We are targeting Phase 3 initiation for the first half of 2013," said Dr. Pablo Lapuerta, chief medical officer at Lexicon. "Further development of LX4211 in type 2 diabetes will focus on demonstrating long-term benefits in glycemic and metabolic parameters and reduction in cardiovascular risk."
Lexicon Conference Call
Lexicon will hold a conference call and webcast at 10:00 a.m. Eastern Time on June 25, 2012 to discuss the LX4211 Phase 2b top-line data. The dial-in number for the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international). The conference ID for all callers is 95092853. Those interested can access the webcast live at www.lexpharma.com. An archived version of the webcast will be available on Lexicon's corporate website for 60 days after the event.
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, characterizations of the results of and projected timing of clinical trials of LX4211, 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.