Clinical Data reported positive top-line results from the second of two Phase III trials with vilazodone in major depressive disorder (MDD). Clinical Data will use results from both late-stage studies to file its NDA by the end of this year. The company’s stock rose 12% to open the day at $15.72.
This second Phase III study was a randomized, double-blind, placebo-controlled trial of 481 patients with MDD. The study achieved its primary and secondary endpoints of reducing depression symptoms as measured by two scales. Study results also suggest that vilazodone was generally well-tolerated and that effects of vilazodone on sexual function were comparable to placebo.
These results along with the fact that Vilazodone has a novel dual mechanism of action bodes extrememly well for drug approval, points out Drew Fromkins, president and CEO. It is both a potent and selective serotonin reuptake inhibitor and a partial agonist of the 5-hydroxytryptamine 1a receptor.
The treatment of depression is a key factor in the high cost of the disease, since patients do not see significant changes on current therapies quickly enough. He believes that results from clinical trials has shown that Vilazodone if approved will be a differenting product in a very large market.
The Phase III study, however, could not replicate its biomarker that had been identified in the first late-stage trial as potentially associated with response to vilazodone. “While our lead biomarker of response to vilazodone did not replicate in this trial, it is one in a series of candidate biomarkers that we will continue to evaluate,” says Carol R. Reed, M.D., evp and CMO.
Clinical Data, which shed its genomic services division through a $17 million deal with Beckman Coulter, continues to use its biomarker capabilities for drug development. The company’s strategy is to couple biomarker R&D with drug R&D to improve drug development and trial design. This usually begins very early in development, but Vilazodone started in Phase III, which is when the drug was inlicensed.
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