|Clinical Data Initiates Pivotal Phase III Trial for Novel Antidepressant|
Thursday January 26, 8:00 am ET
First Ever Pharmacogenomic Screening Tool for Antidepressant to be Developed Concurrently
Maybe should have posted to the defunct Genaissance thread ?
Though this one seems more active...
NEWTON, Mass.--(BUSINESS WIRE)--Jan. 26, 2006--Clinical Data, Inc. (NASDAQ: CLDA - News), a worldwide leader in commercializing pharmacogenomics to guide drug utilization, announced today that the Company will begin enrollment of a pivotal Phase III clinical trial for vilazodone, a novel compound being studied for treatment of depression, and anticipates having initial results from this study available by mid-2007. The successful 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."
Vilazodone is a novel, dual serotonergic antidepressant. It is both a Selective Serotonin Reuptake Inhibitor (SSRI) and a 5HT1A partial agonist. The compound has been assessed in 15 phase I and five phase II trials involving a total of 369 healthy subjects and 1163 depressed patients. Vilazodone has been found to have an acceptable safety profile for this stage of development. In previous trials with positive controls, vilazodone failed to demonstrate significant efficacy against placebo but demonstrated efficacy comparable to that of the positive control, an approved antidepressant in wide use. The rights to develop and commercialize vilazodone were acquired from Merck KGaA of Darmstadt, Germany, in September 2004.
Clinical Trial Design
This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone. The trial will enroll approximately 400 adult patients diagnosed with Major Depressive Disorder at eight US centers. Potential biomarkers will be examined for each clinical subject, and the genetic analysis will be performed in-house by the company at its GLP- and CLIA-approved facilities, which perform similar genetic services for many major pharmaceutical companies. At least one long-term safety study, which has yet to be reviewed by the FDA, will be required prior to NDA filing. The Company is hopeful that clinical subjects from each of the pivotal efficacy trials will participate in the long-term safety studies.