Lexicon's Drug Candidate LX6171 for Cognitive Disorders Completes Phase 2A Clinical Trial
* No Significant Cognitive Effects Observed in Subjects with Age-Associated Memory Impairment
* Future LX6171 Clinical Development Plans to be Re-evaluated
* Phase 2 Development Resources to be Focused on LX1031 for Irritable Bowel Syndrome and LX1032 for Carcinoid Syndrome
THE WOODLANDS, Texas, Dec. 12, 2008--(GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has completed a Phase 2a clinical trial of LX6171 in a study designed to explore the potential effects of the drug candidate in subjects with age-associated memory impairment (AAMI). Although the compound was well tolerated, there was no clear demonstration of activity for the various cognitive domains evaluated.
"Even though there were isolated instances of activity in the recently-completed Phase 2a study, we believe that the aggregate data do not support further development of LX6171 for cognitive impairment at this time," said Philip M. Brown, M.D., J.D., senior vice president of clinical development at Lexicon. "However, the target of LX6171 continues to be intriguing, as this pathway has recently been associated with schizophrenia in human genetic studies. LX6171, which has demonstrated a favorable safety profile in studies conducted to date, has not been tested in that indication."
"Although we are disappointed with the clinical trial results for LX6171, our portfolio strategy enables us to focus our resources on those programs that are seen to have the greatest opportunity for ultimate success in clinical development," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer at Lexicon. "We will evaluate interest from third parties in the compound and its target for other neurobehavioral indications where the target may be relevant, such as schizophrenia."
Lexicon will concentrate its ongoing clinical development efforts on four drug candidates: two drug candidates that are currently in Phase 2 development for irritable bowel syndrome and carcinoid syndrome, LX1031 and LX1032, as well as two drug candidates for rheumatoid arthritis and diabetes that are currently in early-stage clinical development.
In the recently-completed Phase 2a clinical trial, daily doses of LX6171 or placebo were given to 121 healthy elderly subjects with AAMI. The study evaluated safety, tolerability, and cognitive effects of LX6171 over four weeks. Although LX6171 was well tolerated at all doses evaluated, the trial did not result in significant effects on parameters of attention or memory that would justify further studies in therapeutic indications prioritized by the company.
Clinical development of LX6171 has been funded through a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company's research team. Lexicon's goal is to advance 10 drug candidates into human clinical trials by the end of 2010, the strategic objective of its 10TO10 program. The company has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has applied small molecule chemistry and antibody technology to 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.
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Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX6171, LX1031 and LX1032 and the potential therapeutic and commercial potential of LX6171, LX1031 and LX1032. 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 LX6171, LX1031 and LX1032 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 "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2007, 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.
Contact for Lexicon: Bobbie Faulkner Manager, Investor and Public Relations 281/863-3503 firstname.lastname@example.org
Posted: December 2008