Lexicon Pharmaceuticals reports positive results from Phase 2 clinical trials for IBS and type 2 diabetes

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2009.  

"We have now established proof-of-concept for two of our four clinical programs, with positive results in Phase 2 clinical trials for both LX1031 in IBS and LX4211 in type 2 diabetes," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon.  "We look forward to reporting Phase 2 clinical results from our next two programs, LX2931 for rheumatoid arthritis and LX1032 for carcinoid syndrome."

Key Developments of 2009

• Lexicon reported positive results from the Phase 2a clinical trial of its drug candidate for non-constipating irritable bowel syndrome (IBS), LX1031, an inhibitor of tryptophan hydroxylase that acts locally to reduce serotonin synthesis in the gastrointestinal tract.  Top-line data demonstrated that the high dose of LX1031 produced statistically-significant improvements in a global assessment of relief of IBS pain and discomfort and in stool consistency as compared to placebo — clinical benefits that correspond with a reduction in serotonin synthesis.
• Lexicon completed Phase 2a studies of its drug candidate for type 2 diabetes, LX4211, an inhibitor of sodium-glucose cotransporter 2 (SGLT2).  Top-line data from the Phase 2a trial, reported in January 2010, showed statistically-significant and rapid improvements in multiple parameters in patients with type 2 diabetes, including improved glycemic control and reduced HbA1c within four weeks. In addition, reductions in weight, blood pressure, and triglyceride levels were observed for both treatment arms relative to placebo.
• Lexicon advanced LX2931, an inhibitor of sphingosine-1-phosphate (S1P) lyase, into a Phase 2a study in patients with rheumatoid arthritis.  The Phase 2 clinical trial is designed as a 12-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX2931 and its effects on symptoms associated with rheumatoid arthritis. With enrollment in the study proceeding ahead of schedule, the Company has filed for regulatory authorization to permit enrollment of up to 200 patients, an increase from the originally-planned enrollment of up to 120 patients, which will increase the likelihood of observing a positive statistical trend. The study is being conducted at multiple centers in the United States and Eastern Europe.  Top-line data from the expanded trial are expected to be available around the end of the year.
• Lexicon continues to enroll patients in a Phase 2a study of its drug candidate for carcinoid syndrome, LX1032, an inhibitor of tryptophan hydroxylase that reduces peripheral serotonin production without affecting brain serotonin levels.  The Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1032 and its effects on symptoms associated with carcinoid syndrome.  The study is expected to include up to 28 patients with carcinoid syndrome who are symptomatic despite treatment with currently available therapy.  Top-line data from the trial are expected to be available in the second half of 2010.
• In October 2009, Lexicon completed the public offering and sale of 38.3 million shares of its common stock at $1.50 per share.  The net proceeds of the offering were $55.2 million, after deducting underwriting discounts and offering expenses.  

LX1031 and LX1032 are being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.

Financial Results

Revenues:  Lexicon's revenues for the three months ended December 31, 2009 decreased 78 percent to $1.4 million from $6.4 million for the corresponding period in 2008.  The decrease was primarily attributable to reduced revenues under Lexicon's alliances with N.V. Organon, Bristol-Myers Squibb and Genentech, Inc., partially offset by increases in revenue under the company's collaboration with Taconic Farms, Inc.  For the year ended December 31, 2009, revenues decreased 67 percent to $10.7 million from $32.3 million for the corresponding period in 2008.

Research and Development Expenses:  Research and development expenses for the three months ended December 31, 2009 decreased 16 percent to $18.8 million from $22.4 million for the corresponding period in 2008.  The decrease was primarily attributable to lower external preclinical research and development expenses as well as lower salary and benefit costs, partially offset by higher external clinical research and development expenses.  For the year ended December 31, 2009, research and development expenses decreased 24 percent to $81.2 million from $107.2 million for the corresponding period in 2008.

General and Administrative Expenses:  General and administrative expenses for the three months ended December 31, 2009 decreased nine percent to $4.4 million from $4.9 million for the corresponding period in 2008.  The decrease was primarily attributable to lower consulting and stock-based compensation expenses.  For the year ended December 31, 2009, general and administrative expenses decreased 10 percent to $19.4 million from $21.6 million for the corresponding period in 2008.

Net Loss Attributable to Lexicon Pharmaceuticals, Inc.:  Net loss for the three months ended December 31, 2009 was $22.0 million, or $0.13 per share, compared to a net loss of $15.4 million, or $0.11 per share, in the corresponding period in 2008.  Net loss for the year ended December 31, 2009 was $82.8 million, or $0.57 per share, compared to a net loss of $76.9 million, or $0.56 per share, for the corresponding period in 2008.  For the three months and year ended December 31, 2009, net loss included non-cash, stock-based compensation expense of $1.2 million and $5.3 million, respectively.  For the three months and year ended December 31, 2008, net loss included non-cash, stock-based compensation expense of $1.7 million and $6.5 million, respectively.  

Cash and Investments:  As of December 31, 2009, Lexicon had $125.1 million in cash and investments net of its obligations under the credit line secured by its auction rate securities, as compared to $87.3 million as of September 30, 2009 and $158.8 million as of December 31, 2008.  

SOURCE Lexicon Pharmaceuticals, Inc.