EPIX Pharmaceuticals to Present Phase 2a Alzheimer's Data at Keystone Symposia
EPIX previously announced the compelling results of a Phase 2a clinical trial of PRX-03140 as a single agent and in combination with Aricept(R) in patients with mild Alzheimer's disease. Dr. Megerian's presentation will focus on these previously reported data.
PRX-03140 is part of EPIX's strategic partnership with GlaxoSmithKline. The companies have been working together to design and initiate the Phase 2b clinical program. EPIX recently announced that this proof of concept program consists of two clinical trials - PRX-03140 as monotherapy and PRX-03140 in combination with donepezil. EPIX expects to initiate these trials in the first half of 2008, and both trials will address a larger patient population and a longer duration of therapy than the successful two-week Phase 2a trial.
PRX-03140 is a novel, oral investigational drug candidate for Alzheimer's disease. It is selective for the 5-HT4 receptor in the brain and is believed to stimulate both acetylcholine production/release - which enables symptomatic improvement in Alzheimer's patients - and the alpha-secretase pathway - which slows Alzheimer's disease progression. Recent Phase 2a results indicated that patients receiving daily oral 150 mg doses of PRX-03140 as monotherapy achieved a mean 3.6 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) versus a 0.9 point worsening in patients on placebo (p= 0.021). The ADAS-cog endpoint is the current standard for evaluating drug efficacy for cognition in Alzheimer's disease and is an established and accepted registration endpoint. In three Phase 1 trials and the Phase 2a trial, with more than 180 patients and healthy subjects, PRX-03140 has been well-tolerated. In a 14-day Phase 1b clinical trial, treatment with PRX-03140 resulted in changes in brain wave activity in Alzheimer's patients that are consistent with those seen in clinical trials with currently approved drugs for Alzheimer's disease. In preclinical studies, PRX-03140 has shown to improve cognitive function through increasing levels of acetylcholine, and has led to increased levels of soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory.
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma. For more information, please visit the company's website at www.epixpharma.com.
This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations and assumptions concerning the timing and content of corporate presentations and the timing of initiation of clinical trials of PRX-03140. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; failure to obtain the financial resources to complete development of product candidates; our inability to further identify, develop and achieve commercial success for new products and technologies; our inability to achieve commercial success for our products and technologies; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.
Kim C. Drapkin, 781-761-7602
Chief Financial Officer
Keri Mattox, 215-791-0105
Posted: March 2008