The presentation highlighted data from a randomized, double-blind, placebo-controlled Phase 3 study of PRX-00023 in 311 patients with generalized anxiety disorder (GAD). Top-line results from the trial were announced in September 2006. The primary endpoint of the trial was change from baseline in the Hamilton Rating Scale for Anxiety (HAM-A). PRX-00023 showed a trend (p=0.116) to reduce the level of anxiety versus placebo based on the HAM-A; data from the trial also indicated a statistically significant change in the Montgomery Asberg Depression Rating Scale (MADRS), with p=0.0094. The MADRS measures symptoms of depression and was a pre-specified secondary endpoint in this trial. Results also indicated that PRX-00023 was well-tolerated, there was a low rate of discontinuation due to adverse events and side effects seen were similar to placebo, including impact on sexual function and sleep.
"Although PRX-00023 did not meet the primary endpoint in this Phase 3 trial, we were pleased by our secondary endpoint results - statistically significant MADRS data," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "The MADRS results encouraged us to accelerate our clinical plans for PRX-00023 in major depression. We look forward to the results of our ongoing depression trial in the first half of next year."
In March 2007, EPIX announced the initiation of a randomized, double-blind, placebo-controlled Phase 2b trial in 330 patients with major depressive d isorder (MDD). The 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 MADRS compared with placebo. Data from this trial are expected in the first half of 2008.
PRX-00023 is a novel, highly selective, once-daily, 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 and commercial opportunity for a selective, once-daily, 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. PRX-00023 is the subject of a composition of matter patent held by EPIX which extends through 2024.
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products through the use of proprietary technology to better diagnose, treat and manage patients. The company has five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer's disease, cardiovascular disease and obesity. These drug candidates include PRX-08066 in Phase 2 clinical development for pulmonary hypertension associated with chronic obstructive pulmonary disease, PRX-03140 which is in a Phase 2a clinical trial in Alzheimer's disease, PRX-00023 which is in Phase 2b clinical development to treat major depression, and PRX-07034, which recently completed a Phase 1b trial and is in cli nical development for the treatment of obesity and cognitive impairment. The company also has a blood-pool imaging agent (Vasovist(TM)) approved in 32 countries and marketed in Europe. EPIX 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, timing and results of our clinical development program for PRX-00023 and other drug candidates. 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, 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, 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 Quarterly Report on Form 10-Q.
Kim C. Drapkin, 781-761-7602
Chief Financial Officer
Sheryl Seapy, 949-608-0841