The drug, LX6171 was well-tolerated at all dose levels and showed excellent systemic exposure, Lexicon said. 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, and its co-investors.
“The safety and exposure profile of LX6171 that was observed in Phase I encourages us to proceed with further development,” commented Arthur Sands, president and CEO of Lexicon Pharmaceuticals. “We look forward to progressing LX6171 into phase II clinical trials.”
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.
Lexicon expects to receive full audited results of its phase I trials in the third quarter of 2007 and anticipates filing with European regulatory authorities for approval of its Phase II plans in the fourth quarter. Pending regulatory approval, Lexicon plans to initiate Phase II clinical trials in the first quarter of 2008.