Clinical Data, Inc. Presents Vilazodone Data at 2008 Annual Meeting of the APA

Business Wire,  May 6, 2008  

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Evidence Demonstrates Vilazodone's Potential For The Treatment Of Major Depressive Disorder Poster to Include Data on Candidate Biomarker of Response to Vilazodone

NEWTON, Mass. -- PGxHealth, a division of Clinical Data, Inc. (NASDAQ:CLDA) and a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced today that Karl Rickels, MD, Professor of Psychiatry at the University of Pennsylvania and a prominent clinical investigator who is participating in Vilazodone clinical trials, is presenting a poster at today's Annual Meeting of the American Psychiatric Association on results from the completed Phase III study of Vilazodone announced in September 2007. The poster is entitled, "Vilazodone: Evidence for Efficacy and Tolerability in the Treatment of Major Depressive Disorder." This randomized, double-blind, placebo-controlled, ten-site trial enrolled 410 adult patients with major depressive disorder and achieved the primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to placebo (p =.001).

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

About Vilazodone

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.