Clinical Data, Inc. has announced that the Company will begin enrollment of a pivotal Phase III clinical trial for vilazodone, a compound being studied for treatment of depression, and anticipates having initial results from this study available by mid-2007.
The outcome of this trial would serve as one of two pivotal trials required for a new drug application ("NDA"), which the Company hopes to file with the United States Food & Drug Administration as early as year end 2008.
Carol R. Reed, M.D., the Company's Chief Medical Officer, said, "Following our recent meeting with the staff of the Division of Psychiatry Products of the FDA we are accelerating our development plans for vilazodone and a companion biomarker test."
"We believe this program has the potential to revolutionize the treatment of depression. As part of this trial, Clinical Data will use its expertise in biomarker discovery to identify biomarkers for response to vilazodone."
"We plan to use these biomarkers to develop a test to screen for patients who are likely to benefit from the drug."
"About half of depressed patients do not achieve satisfactory results with current first-line treatment options; we hope to assist physicians in matching a patient with a treatment that is likely to work for that patient. There are no such predictive tests currently available."
"This is a transformative event in the history of Clinical Data," said Clinical Data's President and CEO, Israel M. Stein, M.D.
"The development of a genetic-based, predictive screening tool to guide the use of a novel antidepressant would represent a significant advance in pharmacogenomics and in the treatment of depression."
"While available therapeutics are many, a patient's response is highly individualized, leading to trial-and-error inefficiencies and unnecessary delay in finding effective treatment."