WINSTON-SALEM, NC, USA I May 29, 2013 I Targacept, Inc. (TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, today announced the initiation of a Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB). 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. Because orally administered TC-5214 is eliminated more than 90% unchanged through the bladder, Targacept believes the compound offers potential for a low dose to be beneficial while minimizing systemic side effects characteristic of current therapies and enhancing patient compliance.
“Overactive bladder has a devastating effect on quality of life for millions of individuals, and currently available medications have significant drawbacks,” said Eric Rovner, M.D., Professor of Urology, Medical University of South Carolina, College of Medicine, and an investigator in Targacept’s study. “Based on the novel mechanism and favorable tolerability profile associated with TC-5214, I am encouraged by the potential for this clinical study to support what could be a truly novel therapy for patients who suffer from OAB.”
TC-5214 was associated with exaggerated bladder effects in preclinical studies, including increased urinary retention and beneficial changes in bladder contraction, bladder capacity and frequency of urination. In addition, TC-5214 already has a substantial safety database resulting from prior clinical studies in approximately 2,400 subjects in a different indication.
“With a strong scientific rationale, supportive findings, measurable clinical endpoints and a well-defined regulatory path, we view overactive bladder as a promising indication for development of this advanced compound,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “As NNR science continues to evolve, we believe the potential for TC-5214 in OAB serves as a compelling opportunity to expand our pipeline beyond central nervous system diseases in support of our goal to bring important new therapies to patients.”
About the Phase 2b Study in Patients with OAB
The Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial planned to be 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, which is designed to enroll approximately 750 patients, includes a 3- to 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).
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 and nocturia. 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. It is estimated that approximately 1 in 6 adults in the United States suffer from OAB1.
About Targacept
Targacept is developing a diverse pipeline of innovative NNR Therapeutics™ for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, 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 leverages its scientific leadership and diverse pipeline to attract significant collaborations with global pharmaceutical companies. For more information, please visit www.targacept.com.
SOURCE: Targacept
Post Views: 171
WINSTON-SALEM, NC, USA I May 29, 2013 I Targacept, Inc. (TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, today announced the initiation of a Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB). 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. Because orally administered TC-5214 is eliminated more than 90% unchanged through the bladder, Targacept believes the compound offers potential for a low dose to be beneficial while minimizing systemic side effects characteristic of current therapies and enhancing patient compliance.
“Overactive bladder has a devastating effect on quality of life for millions of individuals, and currently available medications have significant drawbacks,” said Eric Rovner, M.D., Professor of Urology, Medical University of South Carolina, College of Medicine, and an investigator in Targacept’s study. “Based on the novel mechanism and favorable tolerability profile associated with TC-5214, I am encouraged by the potential for this clinical study to support what could be a truly novel therapy for patients who suffer from OAB.”
TC-5214 was associated with exaggerated bladder effects in preclinical studies, including increased urinary retention and beneficial changes in bladder contraction, bladder capacity and frequency of urination. In addition, TC-5214 already has a substantial safety database resulting from prior clinical studies in approximately 2,400 subjects in a different indication.
“With a strong scientific rationale, supportive findings, measurable clinical endpoints and a well-defined regulatory path, we view overactive bladder as a promising indication for development of this advanced compound,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “As NNR science continues to evolve, we believe the potential for TC-5214 in OAB serves as a compelling opportunity to expand our pipeline beyond central nervous system diseases in support of our goal to bring important new therapies to patients.”
About the Phase 2b Study in Patients with OAB
The Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial planned to be 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, which is designed to enroll approximately 750 patients, includes a 3- to 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).
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 and nocturia. 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. It is estimated that approximately 1 in 6 adults in the United States suffer from OAB1.
About Targacept
Targacept is developing a diverse pipeline of innovative NNR Therapeutics™ for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, 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 leverages its scientific leadership and diverse pipeline to attract significant collaborations with global pharmaceutical companies. For more information, please visit www.targacept.com.
SOURCE: Targacept
Post Views: 171
