Targacept, Inc. (TRGT) Announces Plans to Develop Product to Treat Overactive Bladders

Targacept, a biopharmaceutical company, announced plans to develop treatments for overactive bladders (OAB). The company has a diverse pipeline of innovative NNR Therapeutics(TM) for difficult-to-treat diseases and disorders of the nervous system. The announcement described Targacepts plans to pursue development of TC-5214 as a treatment for OAB. The announcement stated that the concept is to use the TC-5214 to develop a unique pharmacokinetic profile, or an analysis of data from a completed clinical program and findings from additional preclinical studies. Phase 2b is intended to begin in 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.”

“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.”

Overactive bladder is a disorder that causes a sudden and frequent urge to urinate. OAB poses a significant reduction in quality of life due to a decreased ability to socialize and participate in normal life activities, sleep disturbances, and decreased emotional well-being. The market research firm Decision Resources estimated that there were approximately 69.5 million people with OAB in the world’s seven major pharmaceutical markets in 2009.

To date, clinical studies involving 2,400 subjects indicate physiological findings believed to be consistent with marketed treatments for overactive bladder. Prior studies have also 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 acts as an agent that blocks the action of receptors and has 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.

Targacept is a biopharmaceutical company engaged in the design, discovery, and development of NNR Therapeutics, a new class of drugs for the treatment of multiple diseases and disorders of the nervous system. NNR Therapeutics selectively target neuronal nicotinic receptors, or NNRs, unique proteins that regulate vital biological functions that are impaired in various disease states. Targacept’s clinical pipeline includes multiple Phase 2 product candidates, all representing first-in-class opportunities. Targacept also pursues collaborations with other global pharmaceutical companies.

For more information, please visit www.targacept.com

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