Clinical Data, Inc. Initiates Second Pivotal Phase III Study Of Vilazodone

Main Category: Depression
Also Included In: Mental Health
Article Date: 17 Mar 2008 - 2:00 PDT

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Clinical Data, Inc. (NASDAQ:CLDA), a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced that it has initiated the second of its two pivotal trials of Vilazodone, the Company's novel drug candidate for the treatment of depression. This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of Vilazodone. It will also further evaluate genetic biomarkers of response to Vilazodone, which may lead to the development of a pharmacogenetic test that would help determine the likelihood of a patient's positive response to the drug.

These biomarkers were identified during the first, successful pivotal trial of Vilazodone. In September 2007, Clinical Data announced that Vilazodone demonstrated both statistical and clinical significance on primary and secondary endpoints for efficacy in its first pivotal trial. Along with the long term safety study of Vilazodone that began in December 2007, the second pivotal trial is intended to support a new drug application (NDA) for Vilazodone. Clinical Data is on-track to file its NDA with the U.S. Food & Drug Administration in 2009.

"Multiple, peer-reviewed studies have been published in 2008 that point to the limited efficacy of currently available antidepressants and that validate the thesis that individuals respond differently to various antidepressents," said Drew Fromkin, President and CEO of Clinical Data. "In the US alone, over 17 million people a year are prescribed one or multiple antidepressants. We believe that pharmacogenetics is essential for addressing the unmet need for reliable drug response, which could lead to decreased therapeutic and medical costs."

"Clinical Data's PGxHealthTM division focuses on the use of genetic biomarkers associated with drug response to guide physicians and patients to the drug or drug class that is most likely to be effective," he added. "This is one approach to 'personalized medicine' that is gaining increased support from health insurers and is an integral part of PGxHealth's development approach for Vilazodone."

The trial will enroll approximately 475 adult patients diagnosed with Major Depressive Disorder at 10 US centers. As in the already completed Phase III study, the primary endpoint will be the mean change from baseline in the Montgomery-Asberg Depression Rating Scale total score compared to placebo.

About Vilazodone

Vilazodone is a dual serotonergic Phase III compound that Clinical Data is developing in parallel with genetic biomarkers to guide its use in the treatment of depression. It is both a Selective Serotonin Reuptake Inhibitor and a 5HT1A partial agonist that 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 pharmacogenetic test with Vilazodone to assist physicians in matching patients with a treatment that is more likely to be effective. 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 genetic biomarkers to help predict the likelihood of a patient's pharmacological response to a given antidepressant.

About PGxHealth™

PGxHealth is a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers. This division of Clinical Data 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™. For more information about PGxHealth, please visit its website at http://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 HealthcareTM. Its PGxHealthTM 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 CogenicsTM 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.

Clinical Data, Inc.