Winston-Salem, North Carolina – Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced that it has completed recruitment of patients in its Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB). The company expects to report top-line results from the study in mid-2014. 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.
“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,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “Targacept is grateful to the many patients, study sites and investigators who have helped us reach this important milestone in the development of TC-5214.”
The ongoing Phase 2b study is a double blind, placebo controlled, randomized, parallel group study being conducted at sites in the United States. The study’s co-primary endpoints 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. The study is designed to randomize approximately 750 patients and includes a 3- or 5-week screening period followed by a 12-week treatment period during which patients receive either one of three doses of TC-5214 (0.5mg, 1mg or 2mg) or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a 2-week follow-up period.
About Overactive Bladder
Overactive bladder is a disorder that causes a sudden and frequent urge to urinate that may be difficult to suppress and may lead to incontinence. OAB poses a significant reduction in quality of life due to a decreased ability to socialize and participate in normal life activities and decreased emotional well-being. It is estimated that approximately 1 in 6 adults in the United States suffer from OAB1.
Targacept is developing an advanced clinical pipeline of NNR Therapeutics™ to treat patients suffering from serious nervous system and gastrointestinal/genitourinary diseases and disorders. Many diseases arise from abnormalities in signaling within and between the brain and other organ systems such as the bladder and the GI tract. Targacept’s NNR Therapeutics™ have the potential to normalize these signaling pathways to provide significant medical benefit. Targacept is dedicated to building health and restoring independence for patients. For more information, please visit www.targacept.com.
Building Health, Restoring Independence®
This press release includes “forward-looking statements” made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding without limitation: the timing for reporting of top-line results from Targacept’s Phase 2b clinical trial of TC-5214 in overactive bladder; or Targacept’s plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including without limitation Targacept’s critical accounting policies and risks and uncertainties relating to: the conduct and results of the ongoing Phase 2b clinical trial of TC-5214, including the performance of third parties engaged to execute such trial, delays resulting from any changes to the applicable protocols and difficulties or delays in the completion of subject enrollment or data analysis; whether positive findings from Targacept’s completed clinical trial of TC-5214 in patients with overactive bladder will be replicated in the ongoing clinical trial of TC-5214; Targacept’s ability to establish additional strategic alliances, collaborations or licensing or other comparable arrangements on favorable terms; Targacept’s ability to protect its intellectual property; and the timing and success of submission, acceptance and approval of regulatory filings. Risks and uncertainties that Targacept faces are described in greater detail under the heading “Risk Factors” in Targacept’s most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Targacept cautions you not to place undue reliance on any forward-looking statement.
In addition, any forward-looking statement in this press release represents Targacept’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Targacept disclaims any obligation to update any forward-looking statement, except as required by applicable law.
NNR Therapeutics™ and Building Health, Restoring Independence® are trademarks or service marks of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.
1Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. May 2003; 20(6):327-36.