Under the company’s collaboration agreement with GlaxoSmithKline (GSK), Epix is entitled to receive a $7.5 million milestone payment from GSK related to the start of the Phase IIb program for PRX-03140 in Alzheimer’s disease.
The Phase IIb proof-of-concept program consists of two clinical trials, a six month trial evaluating PRX-03140 in combination with donepezil and a three month trial studying PRX-03140 as monotherapy. The monotherapy trial is expected to begin later in the second quarter of 2008.
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 three trial arms: placebo, 50mg/daily of PRX-03140, or 150mg/daily of PRX-03140. All patients in the trial must be treated with 10mg of donepezil for at least four months prior to enrollment.
The six month trial is expected to enroll approximately 400 adult patients with Alzheimer’s disease. Changes in the clinician and caregiver-based impressions of change (CIBIC+), measures of behavior and activities of daily living (ADLs) and neuropsychological test battery (NTB) will also be measured.