TorreyPines' NGX267 well tolerated in Ph I trial

USA-based TorreyPines Therapeutics has completed a second Phase I study with NGX267, its drug candidate for Alzheimer's disease. The San Diego-headquartered firm noted that in a previous Phase I study, the agent, administered as single doses, was shown to be well-tolerated in healthy, younger adult males.

This second Phase I study was a double-blind, placebo-controlled, single-ascending dose trial that evaluated the safety, tolerability and pharmacokinetics of NGX267 in healthy males and females between the ages of 65 and 80, reflecting the age of the primary AD population. The trial enrolled 26 volunteers at one center in the USA and demonstrated that NGX267 was well tolerated at single doses up to and including 15mg and that evidence of cholinergic activation was detected at these doses.

TorreyPines noted that exposure levels of NGX267 in trial subjects at doses of 15mg or lower may be comparable to those levels tested in transgenic mouse , which were found to improve behavioral symptoms and lower brain AB42, a toxic peptide that is the major component of amyloid plaques, which are considered a primary histopathological hallmark of the condition.