EPIX Pharmaceuticals Initiates Second Trial in Phase 2b Program for Alzheimer’s Disease
News Jun 13, 2008
EPIX Pharmaceuticals, Inc. has announced that it has begun the second trial in its Phase 2b program in Alzheimer’s disease. This second Phase 2b trial will evaluate PRX-03140, a novel 5-HT4 agonist, as monotherapy for the treatment of Alzheimer’s disease.
The Phase 2b 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 (GSK).
“We have continued to execute our clinical development strategy and are pleased to announce the initiation of our second trial in the Phase 2b program for PRX-03140 so quickly on the heels of the start of our combination trial earlier this month,” said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX.
“Following the announcement of the Phase 2a data of PRX-03140 in Alzheimer’s disease, we have worked closely with GSK to design our Phase 2b clinical program and look forward to our continued collaboration.”
“Current therapies for Alzheimer’s disease leave significant unmet need, especially in improving patient’s symptoms with minimal side effects,” said Hugh Cowley, M.D., head of GSK’s Center of Excellence for External Drug Discovery (CEEDD). “The results from the Phase 2a trial of PRX-03140 showed encouraging data in those patients on PRX-03140 alone and we hope that this larger trial will confirm the benefit seen in the earlier trial.
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, 50 mg/daily of PRX-03140, or 150 mg/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. 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.
This monotherapy trial will also include a three month optional extension that will have the ADAS-cog as the primary endpoint. PRX-03140 has been studied in more than 180 subjects to date and previous clinical trials have shown the drug to be well tolerated.