Clinical Data Announces Positive Results from Phase III Pivotal Trial of Vilazodone for Depression
Potential Genetic Biomarkers for Predicting Response to Vilazodone Identified
Clinical Data, Inc. announced positive results in its pivotal Phase III study of its investigative compound Vilazodone. In the study, the primary and supportive secondary efficacy endpoints were met. In addition, the study separately identified candidate biomarkers for a potential companion pharmacogenetic test for response to Vilazodone. In development for the treatment of depression, Vilazodone combines the mechanisms of action of both a Selective serotonin Reuptake Inhibitor (SSRI) and a 5HT1A partial agonist, making this the only compound which combines two mechanisms used as first and second line treatments for mood disorders.
The 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 -Åsberg Depression Rating Scale total score compared to placebo (p=.001). Vilazodone also met a key secondary endpoint of the study, as measured by mean change from baseline on the Hamilton Depression Rating Scale (p=.022). These two rating scales are the most common psychometric measures of response to antidepressants. The safety profile appears to be similar to currently marketed SSRIs.
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. 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 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.
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