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Targacept Announces Negative Top-Line Results from Phase 2b Trial of TC-5619 in Schizophrenia

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Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, today announced top-line results from a Phase 2b clinical trial of TC-5619 as an augmentation therapy for the treatment of negative symptoms of schizophrenia. In the trial, TC-5619 did not meet the primary outcome measure, change from baseline on the Scale for the Assessment of Negative Symptoms (SANS) after 24 weeks versus placebo. In addition, TC-5619 did not demonstrate improvement on the key secondary measures of cognitive function. TC-5619 exhibited a benign safety and tolerability profile in the study.

“The development of new and innovative treatments for patients suffering from central nervous system disorders is challenging, and the results of this study highlight the risks inherent in trying to address the unmet medical needs that remain in schizophrenia,” said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. “While the results are disappointing, we believe the study was well conducted and provides a robust dataset upon which we have based our decision to not pursue further development of TC-5619 as a treatment for either schizophrenia or Alzheimer's disease. We will focus our efforts on our other ongoing Phase 2b programs, TC-5214 for overactive bladder and TC-1734 for Alzheimer's disease, continue forward with the planned development of TC-6499 for diabetic gastroparesis, and maintain our disciplined approach to executing our business plan which seeks to provide new medicines to improve patients' lives.”

Posted-In: News FDA


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