Lexicon initiates Phase 2 clinical trial of LX4211 in patients with type 2 diabetes mellitus

Sep 15 2009

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced today that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2). LX4211 is Lexicon's fourth drug candidate currently being tested in Phase 2 clinical trials.

"LX4211 offers an opportunity to treat diabetes by increasing urinary glucose excretion through a mechanism of action that is expected to avoid some of the disadvantages of existing diabetes drugs that result in storage of excess glucose," said Brian P. Zambrowicz, Ph.D., executive vice president and chief scientific officer at Lexicon. "By contrast, LX4211 through inhibition of SGLT2 has the potential to reduce caloric load and thereby enhance overall glucose homeostasis in patients with type 2 diabetes."

In the recently completed Phase 1 clinical trial in normal healthy volunteers, LX4211 was well tolerated at all dose levels and produced a dose-dependent increase in urinary glucose excretion. LX4211 also demonstrated a favorable pharmacokinetic profile supporting the potential for once daily dosing. Adverse events were generally mild and were distributed across all dose groups, including the placebo group.

Based on the Phase 1 clinical results, Lexicon has initiated a Phase 2 clinical trial to evaluate the safety and tolerability of two dose levels of LX4211 and its effect on diabetes biomarkers including: fasting blood glucose, urinary glucose excretion and response to oral glucose tolerance testing in patients with type 2 diabetes. The four-week, randomized, double-blind, placebo-controlled study will be conducted in the United States and is expected to enroll 36 patients with type 2 diabetes.

In addition to LX4211, Lexicon has three other drug candidates progressing in Phase 2 clinical trials: LX1031 for irritable bowel syndrome, LX1032 for carcinoid syndrome and LX2931 for rheumatoid arthritis. For more information about Lexicon's clinical development programs, please visit www.lexpharma.com.