News
EPIX Pharmaceuticals Initiates Phase 2b Program in Alzheimer’s Disease
EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced that it has begun its Phase 2b program in Alzheimer’s disease through the initiation of a clinical trial of PRX-03140, its novel 5-HT4 agonist, in combination with donepezil (Aricept®).
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 2b program for PRX-03140 in 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 and a three month trial studying PRX-03140 as monotherapy; the monotherapy trial is expected to begin later in the second quarter.
“This Phase 2b program follows the encouraging results seen in our Phase 2a trial, in which monotherapy treatment with PRX-03140 resulted in a statistically significant change from baseline as well as from placebo on the ADAS-Cog score,” said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. “While our previous two-week trial was primarily designed to address safety, we were excited by the measurable impact on memory and cognition PRX-03140 had on many of the participating patients. Our data indicate that PRX-03140 stimulates acetylcholine release and production in the brain without the peripheral, dose-limiting side effects commonly seen with cholinesterase inhibitors. There remains a significant unmet need for Alzheimer’s disease drug therapies that will improve symptoms with minimal side effects.”
“We are encouraged by the PRX-03140 data we’ve seen to date, and based upon this, we are pleased to see EPIX begin the Phase 2b program with PRX-03140 in Alzheimer’s disease,” said Hugh Cowley, M.D., head of GSK’s Center of Excellence for External Drug Discovery (CEEDD). “We believe that patients with Alzheimer’s disease may ultimately be treated with combination therapy to manage the progression of the disease and to manage effectively the symptoms of Alzheimer’s disease. As a result, we are evaluating PRX-03140 in a combination trial in concert with donepezil as well as in a monotherapy setting.”
Trial Design
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, 50 mg/daily of PRX-03140, or 150 mg/daily of PRX-03140. All patients in the trial must be treated with 10 mg 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. PRX-03140 has been studied in more than 180 subjects to date and previous clinical trials have shown the drug to be well-tolerated.