– Thorough QT Study and Pharmacokinetic Data Presented –
NEWTON, Mass.--(BUSINESS WIRE)-- Clinical Data, Inc. (NASDAQ: CLDA), today announced that data from clinical trials of vilazodone, a novel investigational compound for the treatment of major depressive disorder (MDD), were presented at the annual meeting of the American Society of Health System Pharmacists (ASHP). The presentations include results from two Phase I studies. The first study was a Thorough QT Study which evaluated the potential of vilazodone to prolong the QT interval of the electrocardiogram. The second study evaluated the effect of a gastric pH modifier, pantoprazole, on the bioavailability of vilazodone. A New Drug Application (NDA) for vilazodone was accepted for review by the U.S. Food and Drug Administration (FDA) on May 21, 2010 with January 22, 2011 currently assigned for decision-making by the FDA under the Prescription Drug User Fee Act (PDUFA).
“The results of these studies demonstrate that vilazodone did not prolong the QT interval and that alteration of gastric pH does not adversely affect its pharmacokinetics” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “We are committed to continuing to share the findings from our vilazodone studies, which support its potential for the treatment of MDD.”
ASHP Presentation Summaries:
An Evaluation of the Effect of Vilazodone on Cardiac Safety
Joel Morganroth, M.D., eResearch Technology, Philadelphia, PA et al.
Poster #3-176, Session: Monday, December 6, 2:00 PM – 4:30 PM
This Phase I study assessed the proarrhythmogenic potential of vilazodone (as assessed by evaluation of the QT interval of the ECG) compared to placebo and the active control moxifloxacin. Results of this Thorough QT Study showed that vilazodone, at doses up to 80 mg/day, or twice the intended clinical dose of 40mg/day, did not prolong the QT interval. These findings confirm that vilazodone is unlikely to have proarrhythmogenic potential.
Effect of Gastric pH on the Bioavailability of Vilazodone in Healthy Subjects
James Longstreth, Ph.D., Longstreth & Associates, Inc. et al.
Poster #5-120, Session: Tuesday, December 7, 2:00 PM – 4:30 PM
Results of a Phase I study to determine the effect of increased gastric pH on the relative bioavailability of vilazodone demonstrated that an increase in gastric pH with the concomitant administration of pantoprazole (a proton pump inhibitor that inhibits gastric acid secretion by 85%1) had no effect on the bioavailability or pharmacokinetics of a single 40mg dose of vilazodone. These data show that dose adjustment would not be required in patients with MDD who are taking gastric pH modifiers.
Depression is a highly prevalent mood disorder with significant morbidity and mortality. The National Institute of Mental Health estimates that MDD affects approximately 18.1 million adults in the U.S. Further, approximately 60% of MDD patients have a comorbid psychiatric condition, such as anxiety-related disorders and posttraumatic stress disorder.2 Despite advances in the understanding of pharmacotherapy and the ongoing development of new agents, overall effectiveness is unsatisfactory and approximately two-thirds of patients do not achieve remission with first-line depression therapies.3 More than 212 million prescriptions were written for antidepressants in 2009, and commonly prescribed therapies accounted for approximately $12 billion.4
Vilazodone is a novel dual-acting modulator of serotonin neurotransmission in development for the treatment of MDD with the potential for follow-on indications. Vilazodone has a unique mechanism of action and is a serotonin 1A receptor partial agonist and reuptake inhibitor. Vilazodone, to which Clinical Data holds exclusive worldwide rights from Merck KGaA, Darmstadt, Germany, is currently under review by the FDA with a PDUFA date of January 22, 2011. Nearly 2,900 patients have been exposed to vilazodone in the clinical development program. The efficacy of vilazodone in the treatment of MDD was shown to be superior to placebo in two randomized, Phase III clinical trials. Results of an uncontrolled long-term safety study were consistent with the findings of the placebo-controlled studies. The most common adverse events associated with vilazodone in clinical trials were diarrhea, nausea, and insomnia. Vilazodone is currently not approved for marketing by the FDA.
About Clinical Data, Inc.
Clinical Data’s mission is to develop first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in major therapeutic areas including oncology and inflammatory diseases. Clinical Data plans to differentiate its therapeutics by combining its drug development and biomarker expertise in an effort to develop products with enhanced efficacy and tolerability, improving patient health and reducing costs. To learn more, please visit the Company's website at www.clda.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to obtain regulatory approval for, and successfully introduce, vilazodone and our other drug candidates; our ability to expand our long-term business opportunities; and all other statements regarding future performance. All such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements contained in this press release. These risks and uncertainties include, but are not limited to, whether vilazodone or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, vilazodone or any of our other therapeutic products will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether vilazodone or any of our other therapeutic products will be successfully marketed if approved; the strength of our intellectual property rights, including, but not limited to, our patents for the various polymorphic versions of vilazodone; competition from pharmaceutical, biotechnology and diagnostics companies; general economic conditions; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to publish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2010, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2010, and Current Reports on Form 8-K filed from time to time by the Company.
1Protonix® (pantoprazole sodium) delayed-release tablets [package insert].
2Rush A. John et al. Comorbid psychiatric disorders in depressed outpatients: Demographic and clinical features. J Affect Disord 2005 Jul 87 (1):43-55
3STAR*D Study, January, 2006 American Journal of Psychiatry
4IMS Health’s National Prescription Audit and National Sales Perspective
Clinical Data, Inc.
Theresa McNeely, 617-467-6673
Vice President, Corporate Communications
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Pharmaceutical FDA