Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

May 29 2013

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of a Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB). 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. Because orally administered TC-5214 is eliminated more than 90% unchanged through the bladder, Targacept believes the compound offers potential for a low dose to be beneficial while minimizing systemic side effects characteristic of current therapies and enhancing patient compliance.

“With a strong scientific rationale, supportive findings, measurable clinical endpoints and a well-defined regulatory path, we view overactive bladder as a promising indication for development of this advanced compound”

"Overactive bladder has a devastating effect on quality of life for millions of individuals, and currently available medications have significant drawbacks," said Eric Rovner, M.D., Professor of Urology, Medical University of South Carolina, College of Medicine, and an investigator in Targacept's study. "Based on the novel mechanism and favorable tolerability profile associated with TC-5214, I am encouraged by the potential for this clinical study to support what could be a truly novel therapy for patients who suffer from OAB."

TC-5214 was associated with exaggerated bladder effects in preclinical studies, including increased urinary retention and beneficial changes in bladder contraction, bladder capacity and frequency of urination. In addition, TC-5214 already has a substantial safety database resulting from prior clinical studies in approximately 2,400 subjects in a different indication.

"With a strong scientific rationale, supportive findings, measurable clinical endpoints and a well-defined regulatory path, we view overactive bladder as a promising indication for development of this advanced compound," said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. "As NNR science continues to evolve, we believe the potential for TC-5214 in OAB serves as a compelling opportunity to expand our pipeline beyond central nervous system diseases in support of our goal to bring important new therapies to patients."

SOURCE Targacept, Inc.