THE WOODLANDS, Texas, Sept. 6 /PRNewswire-FirstCall/ -- Lexicon Genetics Incorporated (Nasdaq: LEXG - News) announced today that it has initiated a Phase 1 clinical trial for LX6171, a novel, orally administered small molecule compound for cognitive disorders. The trial initiation follows the clearance in July of Lexicon’s Clinical Trial Authorization (CTA) filing for LX6171 by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA).
The Phase 1 clinical trial of LX6171 is being conducted in normal healthy volunteers to evaluate LX6171’s safety, tolerability and pharmacokinetics. The trial is designed as a randomized, double-blind, ascending single dose study and is expected to include approximately 40 subjects. This trial will be followed by a randomized, double-blind, ascending multiple dose study of similar size.
LX6171 is a selective and potent inhibitor of a novel membrane protein that is expressed exclusively in the central nervous system and is associated with synaptic vesicles and presynaptic membranes. It resulted from Lexicon’s internal target and drug discovery efforts. In preclinical studies, LX6171 demonstrated improved learning and memory in healthy and aged mice. Lexicon is developing LX6171 for potential application in the treatment of cognitive disorders such as Alzheimer’s disease, schizophrenia, vascular dementia, attention deficit disorder and Fragile X syndrome.
“The commencement of human clinical trials for LX6171 marks the advancement of Lexicon’s pipeline of drug discovery programs into development,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Lexicon. “Our internal research and discovery capabilities enable us to develop compounds, such as LX6171, that modulate novel targets and have the potential to address major areas of unmet medical need.”
About Lexicon Genetics
Lexicon Genetics is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon is systematically discovering the physiological and behavioral functions of genes to identify potential points of therapeutic intervention, or drug targets. Lexicon makes these discoveries using its proprietary gene knockout technology to model the physiological effects that could be expected from prospective drugs addressing these targets. For targets that the company believes have high pharmaceutical value, it engages in programs for the discovery and development of small molecule, antibody and protein drugs. Lexicon has advanced knockout-validated targets into drug discovery programs in six therapeutic areas: diabetes and obesity, cardiovascular disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic disease. Lexicon is working both independently and through collaborations and strategic alliances to accelerate the development and commercialization of its discoveries.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s regulatory filings and clinical development program for LX6171 and the potential therapeutic and commercial potential of LX6171 and other potential drug candidates in Lexicon’s preclinical pipeline. 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 and preclinical development of 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 “Business - Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2005, 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 Genetics Incorporated
