Clinical Data, Inc. (NASDAQ: CLDA) announced positive top-line results from the second of two Phase III trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD).
In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase III trial.
In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction. A statistically significant improvement in the symptoms of anxiety associated with MDD was also observed. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of MDD by the end of 2009.
“We are delighted with these top-line Phase III results, which provide further evidence of the potential of vilazodone as a first-in-class drug for the treatment of depression,” said Carol R. Reed, MD, Executive Vice President and Chief Medical Officer of Clinical Data. “Physicians and patients continue to seek new treatment options for MDD. With a new, dual mechanism of action and the potential for a favorable safety profile, we believe that, if approved, vilazodone will have broad clinical utility for the treatment of MDD. The positive results from this study, coupled with the results of the prior Phase III and long-term safety studies, will provide the basis for our NDA filing later this year for vilazodone for the treatment of depression.”
Separately, the Phase III study also sought to replicate a proprietary biomarker that had been identified in the first Phase III trial as potentially associated with response to vilazodone. Although this goal was not met, biomarker analyses remain ongoing. “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,” continued Dr. Reed.
Vilazodone, if approved, would represent a first-in-class drug for the treatment of depression, due to its novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Thus, vilazodone combines first-line therapy for MDD with 5-HT1A partial agonism, an accepted adjunctive treatment for MDD and a first-line therapy for anxiety disorders.
Source: Clinical Data, USA