Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive...( THE WOODLANDS Texas Dec. 5 /- Lex...),Health

THE WOODLANDS, Texas, Dec. 5 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that dosing has commenced in a Phase 2a clinical trial with LX6171, an oral drug candidate for the treatment of cognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia, and vascular dementia. The initial stage of the trial will assess the bioavailability of a new oral-suspension formulation in healthy elderly subjects with a second stage evaluating safety, tolerability and cognitive effects in elderly subjects with age-associated memory impairment (AAMI).

"AAMI is an emerging area of clinical research and offers an expedient population for obtaining proof-of-concept with a drug candidate, like LX6171, that has a broad range of potential applications in the area of cognitive disorders," said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. "Following the strength of the Phase 1 data indicating LX6171 is generally well tolerated, we have adopted a two-stage strategy for Phase 2a in order to transition to our new oral suspension formulation and to assess for improvements in a variety of cognitive dimensions as we enter the elderly population."

Phase 2 Study Design

The initial stage of the trial will assess the bioavailability of a single-dose oral suspension in 16 healthy elderly subjects. The second stage will be a randomized, double-blind, placebo-controlled evaluation of safety, tolerability, and cognitive effects in approximately 120 subjects over four weeks. This stage is anticipated to include three groups of 40 subjects each, exploring two dose levels with a placebo control. Exact dose levels for the second stage wi
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