Targacept plans to pursue development of TC-5214 for overactive bladder

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, today announced that it plans to pursue development of TC-5214 as a treatment for overactive bladder (OAB). Based on TC-5214's unique pharmacokinetic profile, an analysis of data from a completed clinical program and findings from additional preclinical studies, the company plans to initiate a Phase 2b study of TC-5214 in the first half of 2013.    

"Current treatments for OAB have efficacy and tolerability shortcomings that limit their utility for many patients. The extensive renal excretion of TC-5214 suggests that a low dose of the drug should produce high bladder concentrations that could diminish sensations of urgency and be well tolerated," said Michael Chancellor, M.D., Professor, Oakland University, William Beaumont School of Medicine and Chairman of the Urology Department at Beaumont Hospital. "Development of an oral drug with targeted effects at nicotinic receptors located in the bladder would represent a welcomed advance towards a potential new treatment paradigm for patients with OAB."

Completed clinical studies in approximately 2,400 subjects have resulted in a well-established safety and tolerability profile for TC-5214. Targacept's analysis of data from that program, as well as additional preclinical studies, have revealed physiological findings believed to be consistent with marketed treatments for overactive bladder. In addition, prior studies have shown that over 90% of TC-5214 is eliminated unchanged through the bladder, supporting use of a low dose and creating the potential to minimize unwanted systemic effects.

TC-5214 is a nicotinic channel modulator that has been found to act potently at nicotinic receptors located in the bladder. Agents that block the action of these receptors have been shown in animal models to decrease bladder wall contraction frequency and impact nerve signaling from the bladder. Similar effects in clinical trials in OAB would be expected to contribute to symptomatic improvement.

"OAB is an attractive indication for us, as it has objective clinical endpoints, an established regulatory path, and clear opportunity to improve on available treatments and benefit millions of patients whose quality of life is severely diminished," said Mark Skaletsky, Chairman of Targacept's Board of Directors. "This program for TC-5214 builds upon an extensive safety database and preclinical and clinical data that supports the mechanistic rationale."