In Phase I clinical trials, LX6171 was generally well tolerated at all dose levels and showed good systemic exposure with no significant adverse events or cognitive impairment observed. Preliminary data on attention parameters were encouraging and suggest the appropriateness of proceeding with further studies to determine if LX6171 could have a potential effect on cognitive or attention disorders.
LX6171 is currently under evaluation in a Phase II clinical trial to evaluate the safety, tolerability and cognitive effects of LX6171 in approximately 100 elderly subjects with age-associated memory impairment. The placebo-controlled trial will include a low dose group receiving 120mg of the drug candidate once per day, and a higher dose group receiving 240mg once per day. Both groups will receive the drug candidate for 28 days and will be evaluated regularly for effects on several dimensions of learning and memory.
Philip Brown, senior vice president of clinical development at Lexicon, said: “LX6171 may have potential in a broad range of applications involving cognitive disorders, including Alzheimer’s disease, attention disorders, and developmental disorders.”