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UPDATE: Targacept Announces will Discontinue TC-5214 Program, Cites Mixed Results

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Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company advancing NNR Therapeutics™, today announced top-line results from a Phase 2b clinical trial of TC-5214 as a treatment for overactive bladder (OAB). In the trial, the high dose of TC-5214 demonstrated mixed results on the co-primary endpoints by providing a statistically significant reduction in micturition frequency (p=0.033) and an improvement that did not reach statistical significance on episodes of urinary incontinence (p=0.379) per 24 hours, after 12 weeks of treatment. As a consequence of these results, Targacept is discontinuing further development of TC-5214 in OAB.

In this trial, TC-5214 was considered generally safe and well tolerated. However, there was a placebo corrected 15.1% rate of constipation and a 5.9% rate of urinary tract infection in the high dose group. Analyses of the full dataset from the trial are ongoing and Targacept plans to publish more detailed results.

“Although TC-5214 provided dose-dependent efficacy on several endpoints during the course of treatment, the results were not compelling enough to justify the compound's continued development in overactive bladder,” said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. “Assessing these results together with our previous clinical trial outcomes, including data from our most recent trials in schizophrenia and Alzheimer's disease, it is clear that modulation of nicotinic receptors can result in biological effects. However, these effects do not appear to predict new treatments with a meaningful improvement over the current standard of care for the indications studied. Targacept would like to thank the many patients, investigators, study site personnel and operational team members who contributed to making this a well-executed trial.”

Dr. Hill continued, “As part of our scenario planning over the past twelve months, we have considered a broad range of options for the optimal use of our resources, including the pursuit of non-nicotinic opportunities. In the coming months, Targacept will be continuing to carefully evaluate those portfolio options that we believe have the potential both to make a significant difference in patients' lives and provide meaningful upside for our stakeholders. We will be holding a conference call in conjunction with our quarterly earnings release on August 6, 2014.”

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