Lexicon Drug Candidate for Cognitive Disorders Successfully Completes Phase 1 Clinical Trial
Tuesday July 31, 6:30 am ET
- Lead Candidate Advancing To Phase 2 under Symphony Icon Collaboration -
THE WOODLANDS, Texas, July 31 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX - News) today announced that LX6171, an oral drug candidate for cognitive disorders, successfully completed Phase 1 clinical trials. LX6171 was well-tolerated at all dose levels and showed excellent systemic exposure. Over the seven day trial, no dose-limiting toxicities were observed and exposure levels supported a once daily dosing regimen. LX6171 is being developed under a product development collaboration with Symphony Capital Partners, L.P. and its co-investors ("Symphony").
"The safety and exposure profile of LX6171 that was observed in Phase 1 encourages us to proceed with further development," commented Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Lexicon Pharmaceuticals. "We look forward to progressing LX6171 into Phase 2 clinical trials."
The recently completed Phase 1b study of LX6171 was designed as a randomized, double-blind, placebo-controlled, multiple ascending-dose study to evaluate safety, tolerability and pharmacokinetics over seven days of dosing in normal healthy young (age 18-50) and elderly (age 65-80) volunteers. Lexicon expects to receive full audited results of its Phase 1 trials in the third quarter of 2007 and anticipates filing with European regulatory authorities for approval of its Phase 2 plans in the fourth quarter. Pending regulatory approval, Lexicon plans to initiate Phase 2 clinical trials in the first quarter of 2008.
About LX6171
LX6171 is an oral drug candidate that was generated by Lexicon's small molecule drug discovery team and is being developed to treat disorders characterized by cognitive impairment, such as Alzheimer's disease, schizophrenia or vascular dementia. Its target, a membrane protein that is expressed exclusively in the central nervous system, was identified through Lexicon's Genome 5000(TM) program through the study of mouse knockouts that showed enhanced learning and memory. LX6171 is a potent oral inhibitor of its target and reproduces these effects in animal models.
About Symphony Icon
Lexicon entered into a product development collaboration with Symphony in June 2007. Under the terms of the arrangement, $45 million was provided to Symphony Icon, Inc., a newly-created company established to fund and accelerate development of Lexicon's first three product candidates and hold the license to the intellectual property of LX6171, LX1031 and LX1032. An additional $15 million of equity capital was provided directly to Lexicon for general corporate purposes. |
