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www.fdanews.com/articles/96529-lexicon-drug-candidate-for-cognitive-disorders-completes-phase-i-trial

Lexicon Drug Candidate for Cognitive Disorders Completes Phase I Trial

July 31, 2007

Lexicon Pharmaceuticals announced that LX6171, an oral drug candidate for cognitive disorders, successfully completed Phase I clinical trials.

According to Lexicon, 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, the company said.

The recently completed Phase Ib 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, the company added. 

The company said it expects to receive full audited results of its Phase I trials in the third quarter and anticipates filing with European regulatory authorities for approval of its Phase II plans in the fourth quarter.