- On Track to File NDA This Year –
- Conference Call to Discuss Results Today at 8:30 am EST -
Clinical Data, Inc. (NASDAQ: CLDA) today 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.
This second Phase III study was a randomized, double-blind,
placebo-controlled trial of 481 patients with MDD conducted at 12 sites
in the United States. The study achieved its primary endpoint of
demonstrating a reduction in the symptoms of depression, as measured by
a statistical separation from placebo, in the Montgomery-Åsberg
Depression Rating Scale (MADRS) total score after up to 8 weeks of
treatment (p=0.007, ITT/LOCF).
