Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced that it has completed recruitment of patients in its Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB). The company expects to report top-line results from the study in mid-2014. TC-5214 acts potently on alpha3beta4 and other neuronal nicotinic receptors (NNRs) located in or around the bladder that are believed to play a key role in bladder contraction and signaling of the urge to urinate.
"With a strong scientific rationale, supportive findings, measurable clinical endpoints and a well-defined regulatory pathway, we view overactive bladder as a promising indication for developing this advanced compound and believe it has the potential to increase quality of life for the millions of people who suffer from OAB," said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. "Targacept is grateful to the many patients, study sites and investigators who have helped us reach this important milestone in the development of TC-5214."
The ongoing Phase 2b study is a double blind, placebo controlled, randomized, parallel group study being conducted at sites in the United States. The study's co-primary endpoints are change in micturition frequency per 24 hours and change in urinary incontinence episodes per 24 hours, in each case from baseline to 12 weeks. The study is designed to randomize approximately 750 patients and includes a 3- or 5-week screening period followed by a 12-week treatment period during which patients receive either one of three doses of TC-5214 (0.5mg, 1mg or 2mg) or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a 2-week follow-up period.
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