EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has met its enrollment target of 330 patients in U.S. centers for its Phase 2b trial of PRX-00023 in Major Depressive Disorder (MDD). As a result of this rapid enrollment, EPIX expects to announce results of this trial in the first quarter of 2008. Further, EPIX has completed enrollment of its Phase 2a clinical trial of PRX-03140 in Alzheimer's disease and reaffirmed that it is on track to announce the findings of this study by the end of 2007.
"We are very pleased to achieve these significant milestones for these two important clinical trials," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "We believe that the rapid pace at which we were able to recruit patients into the Phase 2b MDD trial is indicative of the interest in, and need for, new and improved treatments for depression."
PRX-00023 Phase 2b in Major Depressive Disorder
PRX-00023 is a novel, highly selective 5-HT1A partial agonist discovered using the company's proprietary G-Protein Coupled Receptors (GPCR) modeling, screening and lead optimization technology. PRX-00023 is targeting a significant unmet medical need for a selective 5-HT1A agonist used in the treatment of depression that avoids the sexual dysfunction, withdrawal symptoms and sleep disturbances typically associated with selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs), lacks the addictive and sedative effects of the benzodiazepines, and does not have the slow onset, short half-life, and side effects of a chemical class of 5-HT1A agonists called azapirones. EPIX has secured composition of matter patent protection for PRX-00023 through 2024.
In the first randomized trial of PRX-00023 conducted last year, 80 mg once daily of PRX-00023 showed significant improvement (p=0.009) in the pre-specified endpoint of MADRS in patients with generalized anxiety disorder. The current randomized, double-blind, placebo-controlled Phase 2b trial is designed to evaluate the effect of treatment with up to 120 mg of PRX-00023 twice-daily for eight weeks as determined by change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) compared with placebo. Patients in the current trial randomized to the drug treatment will begin with 40 mg PRX-00023 twice daily, and increase the dose, if tolerated, to a maximum of 120 mg twice daily within the first week. The trial has met its enrollment target of 330 adult patients with MDD. Changes in the Hamilton Anxiety Score (HAM-A), Clinical Global Impressions Improvement Scale (CGI-I) and Clinical Global Severity of Illness Scale (CGI-S) will be measured as secondary endpoints. PRX-00023 has been studied in more than 250 subjects to date and previous clinical trials have shown the drug to be well tolerated up to 320 mg per day with a low incidence of sexual dysfunction and sleep disorders.
About Major Depressive Disorder
Major depressive disorder (MDD) is a form of depression that is characterized by feelings of intense sadness or hopelessness, loss of interest in once enjoyable activities, insomnia, physical pain that does not respond to treatment, thoughts of death or suicide or any combination of these symptoms. Depressive illness affects an estimated 18.8 million Americans and approximately 121 million people worldwide, according to Espicom, and is predicted by the World Health Organization to be the leading cause of quality life years lost by the year 2020. The global market for antidepressive drugs is growing at a rate of 2% per year, with global sales of $16.2 billion in 2005, as reported by Espicom.
PRX-03140 in Alzheimer's Disease
PRX-03140 is EPIX's second of four clinical drug candidates discovered utilizing its proprietary computer-based G-Protein Coupled Receptors (GPCR) models and optimized with integrated computational-medicinal chemistry. PRX-03140 is selective for the 5-HT4 receptor in the brain, and preclinical studies have shown that it may improve cognitive function and increase levels of acetylcholine, soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory. GlaxoSmithKline has an exclusive option to license PRX-03140 for further development and commercialization on a worldwide basis once EPIX has achieved clinical proof of concept.
This Phase 2a clinical trial is designed to further evaluate PRX-03140 as monotherapy and in combination with donepezil (Aricept®) for the treatment of Alzheimer's disease. The current Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRX-03140 administered orally once-daily stable dose of 10mg donepezil.
About Alzheimer's Disease
Alzheimer's disease is a debilitating neurodegenerative disorder characterized by progressive loss of memory and cognitive function, affecting 4.5 million Americans according to the Alzheimer's Association, and over 9 million worldwide according to the Alzheimer's Disease International Association. The U.S. National Institute of Aging estimates that about 5% of the population aged 65-74 and as many as 50% of those over age 85 have the disease. The global market for Alzheimer's disease drugs is growing rapidly, from $3 billion in 2004 to nearly $7 billion expected in 2010, as estimated by Espicom.
Acetylcholinesterase (AChE) inhibitors, a class of drugs approved for the treatment of Alzheimer's disease that includes donepezil (Aricept®), are active in patients provided that endogenous production of ACh is sufficient to maintain local levels. As Alzheimer's disease progresses, ACh production declines, and brain levels of this critical neurotransmitter decline. In parallel with effective therapeutics in other neurodegenerative diseases (e.g., Parkinson's disease), replacement of the prominent neurotransmitter lost in Alzheimer's disease should provide significant clinical benefit. However, neither ACh nor its components can be given in sufficient quantities to increase brain ACh levels with tolerable side effects. The search for agents that increase the production and/or release of ACh, which can be used alone or in combination with AChE inhibitors, may therefore yield a drug candidate with significant clinical benefit. Early data suggest PRX-03140 may meet this need.
About EPIX
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 AG, Germany. 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 regarding the progress and timing of results of our clinical development program for PRX-00023 and PRX-03140 and their efficacy and potential commercial success. 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. In particular, the risks and uncertainties include, among other things: risks that product candidates, including PRX-00023 and PRX-03140, may fail in the clinic or may not be successfully marketed or manufactured; risks relating to the our ability to advance the development of product candidates currently in the pipeline or in clinical trials, any failure to comply with regulations relating to our products and product candidates, including FDA requirements; failure to obtain the financial resources to complete development of product candidates; the risk that the FDA may interpret the results of our studies differently than we have; competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; the possibility of delays in the research and development necessary to select drug development candidates; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. 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.
