Epix initiates second trial in Phase IIb Alzheimer’s disease study

The Phase IIb proof-of-concept program consists of two clinical trials – a six-month trial evaluating PRX-03140 in combination with donepezil that began earlier this month and this three-month trial studying PRX-03140 as monotherapy. PRX-03140 is part of Epix’s strategic collaboration with GlaxoSmithKline.

This randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy of PRX-03140 on cognitive function as measured by the change from baseline in the cognitive component of the Alzheimer’s disease assessment scale (ADAS-Cog) score.

The ADAS-Cog endpoint is the current standard for evaluating drug efficacy for cognition in Alzheimer’s disease and is an established and accepted regulatory endpoint. Patients will be randomized to one of four trial arms: placebo, donepezil positive control, 50mg/daily of PRX-03140, or 150mg/daily of PRX-03140.

The three month trial is expected to enroll approximately 240 adult patients with Alzheimer’s disease that are either intolerant to acetylcholinesterase inhibitors or are newly diagnosed. This monotherapy trial will also include a three month optional extension that will have the ADAS-cog as the primary endpoint.