Clinical Data, Inc. Presents Vilazodone Data at 2008 Annual Meeting of the APA
The presentation also includes an example of the proprietary genetic biomarkers identified during the Phase III trial and a statistical comparison of Vilazone-treated patients who were biomarker positive with those who were biomarker negative. The biomarker described in the poster identifies patients who have significantly more improvement after 8 weeks of treatment with Vilazodone (p = 0.000013) compared to Vilazodone-treated patients without the biomarker. The Vilazodone-treated patients who were biomarker negative responded as though they were treated with placebo. This biomarker is one of a set of candidate biomarkers being investigated for the development of a proprietary companion pharmacogenetic test for response to Vilazodone. The second Phase III study of Vilazodone, which is already underway, will further examine this set of biomarkers.
The results of this 8-week trial demonstrate that Vilazodone treatment leads to a statistically significant reduction in depressive symptoms in patients with major depressive disorder. Vilazodone-treated patients showed greater improvement compared to placebo for mean change from baseline on the MADRS, the trial's primary endpoint, as well as on the Hamilton Score for Depression and the Hamilton Score for Anxiety (p = 0.001, 0.02, and 0.03, respectively). There were significantly more responders in the Vilazodone group (p = 0.02).
Vilazodone's safety profile suggests that it is well tolerated. In this trial, the most common treatment-emergent adverse events included diarrhea, nausea, dizziness, and somnolence, and most were mild or moderate in intensity. Self-reported scores on the Arizona Sexual Experience Scale were not different between the treatment and placebo groups on any dimension of sexual function after 8 weeks of treatment.
"The data we are presenting at APA demonstrate Vilazodone's potential as a treatment for Major Depressive Disorder," said Dr. Rickels. "Vilazadone's unique dual mechanism of action could make it a first-in-class compound on a stand-alone basis. A companion genetic test, that could potentially identify the patients most likely to respond to Vilazodone, would also be a very exciting addition to the armamentarium of treatment for major depressive disorder."
"We believe that a diagnostic combined with a therapeutic in this drug class could, if approved, be a major step forward in the treatment of depression, as approximately one-half of depressed patients do not achieve satisfactory results with current first-line treatment options," added Carol R, Reed, MD, Chief Medical Officer of Clinical Data. "We also believe that such a combination would provide a compelling model for the use of pharmacogenetics in the development of more targeted therapies in a variety of drug classes. We remain on-track to submit a New Drug Application for Vilazodone in 2009."
Dr. Rickels is presenting the poster from 3:00 to 5:00pm ET on Tuesday, May 6. The poster will be available at www.clda.com after the APA's meeting concludes on May 8.
For more information about the conference please refer to http://www.psych.org/APAStory/Annual%20Meeting.aspx
Vilazodone is a dual serotonergic Phase III antidepressant that Clinical Data is developing in parallel with genetic biomarkers to guide the use of this novel antidepressant. Vilazodone combines the mechanisms of action of both a Selective Serontonin Reuptake Inhibitor (SSRI) and a 5HT1A partial agonist, which could make it a first-in-class compound, and it has been found to have an acceptable safety profile for this stage of development. As approximately one-half of depressed patients do not achieve satisfactory results with current first-line treatment options, Clinical Data hopes to develop a product that combines a genetic test with Vilazodone to assist physicians in matching patients with a treatment that is more likely to be effective for each patient in the first instance. The worldwide rights to develop and commercialize Vilazodone were acquired from Merck KGaA of Darmstadt, Germany, in September 2004.
About Depression and the Antidepressant Market
The Surgeon General's Office estimates that 5.3% of American adults, approximately 17 million people, suffer from depressive illness. According to the company's estimates, antidepressants generated sales of more than $12 billion in 2006 in the U.S. It is believed that some people may be genetically predisposed to depression and that it may be possible to identify certain genetic biomarkers that might help to predict the likelihood of a patient's pharmacological response to a given antidepressant.
This division of Clinical Data, Inc. has extensive experience and capabilities in the development, clinical validation and delivery of genetic tests that assist providers in targeting efficacious and safe drugs for their patients. PGxHealth also leverages its capabilities and intellectual property to develop therapeutics which are targeted at patient subpopulations where drug response is enhanced. Through its know-how and resources, work conducted with some of the world's most prestigious genomics thought leaders and institutions, and use of innovative technologies, PGxHealth is focused on reducing treatment costs and improving clinical outcomes in those disease states and therapeutic classes beset with expensive, inefficient or suboptimal treatment options. It has branded its genetic tests based on these proprietary genetic markers as Therapeutic Diagnostics(TM). For more information about PGxHealth, please visit its website at www.pgxhealth.com.
About Clinical Data, Inc.
Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, From Targeted Science to Better Healthcare(TM). Its PGxHealth(TM) division focuses on proprietary biomarker and pharmacogenetic test development as well as targeted therapeutics to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics(TM) division provides genomics services to both research and regulated environments. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists and health plans worldwide. Visit the company's website at www.clda.com for more information.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to successfully integrate the operations, business, technology and intellectual property obtained in our acquisitions; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, whether vilazodone will advance further in the clinical trials process and whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether vilazodone will be successfully marketed if approved; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2007, Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2007, and Current Reports on Form 8-K filed from time to time by the Company.
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Posted: May 2008