Targacept, a clinical-stage biopharmaceutical company, has announced plans to develop TC-5214 as a treatment for overactive bladder (OAB).
TC-5214 is a nicotinic channel modulator that acts potently at nicotinic receptors located in the bladder, thereby decreasing the bladder wall contraction frequency and impacting nerve signalling.
Beaumont Hospital urology department chairman and Oakland University William Beaumont School of Medicine professor Dr Michael Chancellor said current treatments for OAB have efficacy and tolerability shortcomings that limit their benefit 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," Chancellor said.
"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."
The company plans to begin a Phase IIb study of TC-5214 in the first half of 2013.
Prior studies have shown that over 90% of TC-5214 is eliminated unchanged through the bladder, supporting the use of a low dose and creating the potential to minimise unwanted systemic effects, according to the company.
Targacept board of directors chairman Mark Skaletsky said OAB has objective clinical endpoints, an established regulatory path, and provides a clear opportunity to improve on available treatments.
"This program for TC-5214 builds upon an extensive safety database and preclinical and clinical data that supports the mechanistic rationale," Skaletsky said.