US-based biopharmaceutical firm Targacept has completed patient recruitment for its Phase IIb clinical trial of TC-5214 for the treatment for overactive bladder (OAB).
Targacept develops new neuronal nicotinic receptor (NNR) Therapeutics, and expects to report top-line results from the trial in mid-2014.
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According to the company, TC-5214 acts potently on alpha3beta4 and other NNRs located in or around the bladder that are believed to play a vital role in bladder contraction and signaling of the urge to urinate.
The double blind, placebo-controlled, randomised, parallel group Phase IIb trial is being carried out at sites in the US.
Co-primary endpoints in the trial 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.
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The trial is designed to randomise about 750 patients and includes a three or five-week screening period followed by a 12-week treatment period.
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By GlobalDataDuring the trial period patients will be given either one of three doses of TC-5214 (0.5mg, 1mg or 2mg) or placebo twice daily, randomised in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period.
Targacept president and chief executive officer Stephen Hill said: "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."
Overactive bladder is a disorder that causes a sudden and frequent urge to urinate that may be difficult to suppress and might lead to incontinence.
The disorder poses a significant reduction in quality of life due to a decreased ability to socialise and participate in normal life activities and decreased emotional well-being.
Image: The hallmark symptom of overactive bladder is urgency. Photo: courtesy of freedigitalphotos.net.
