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Targacept, Inc.
, 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.”
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