The randomized, double-blind, placebo-controlled study of 410 adult patients with major depressive disorder achieved the primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale total score compared to the placebo.
Vilazodone also met a key secondary endpoint during the study, as measured by mean change from baseline on the Hamilton Depression Rating Scale. These two rating scales are the most common psychometric measures of response to antidepressants.
The study also identified candidate biomarkers for a potential companion test for predicting the response to Vilazodone. According to Clinical Data, Vilazodone is the only compound that combines two mechanisms used as first and second line treatments for mood disorders.
Drew Fromkin, president and CEO of Clinical Data, said: “This positive result with Vilazodone to date, coupled with our demonstrated ability to bring proprietary, pharmacogenetic tests to market, signals a new era for Clinical Data.”
Carol Reed, Clinical Data’s chief medical officer, added: “The implications for patients suffering from depression are exciting. We look forward to meeting with the FDA to discuss our remaining clinical trials program in support of our NDA filing on this important new therapeutic candidate and on a potential genetically based companion diagnostic.”