WINSTON-SALEM, N.C.--(BUSINESS WIRE)--Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company advancing NNR Therapeutics™, today announced top-line results from a Phase 2b clinical trial of TC-5214 as a treatment for overactive bladder (OAB). In the trial, the high dose of TC-5214 demonstrated mixed results on the co-primary endpoints by providing a statistically significant reduction in micturition frequency (p=0.033) and an improvement that did not reach statistical significance on episodes of urinary incontinence (p=0.379) per 24 hours, after 12 weeks of treatment. As a consequence of these results, Targacept is discontinuing further development of TC-5214 in OAB.
In this trial, TC-5214 was considered generally safe and well tolerated. However, there was a placebo corrected 15.1% rate of constipation and a 5.9% rate of urinary tract infection in the high dose group. Analyses of the full dataset from the trial are ongoing and Targacept plans to publish more detailed results.
“Although TC-5214 provided dose-dependent efficacy on several endpoints during the course of treatment, the results were not compelling enough to justify the compound’s continued development in overactive bladder,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “Assessing these results together with our previous clinical trial outcomes, including data from our most recent trials in schizophrenia and Alzheimer’s disease, it is clear that modulation of nicotinic receptors can result in biological effects. However, these effects do not appear to predict new treatments with a meaningful improvement over the current standard of care for the indications studied. Targacept would like to thank the many patients, investigators, study site personnel and operational team members who contributed to making this a well-executed trial.”
Dr. Hill continued, “As part of our scenario planning over the past twelve months, we have considered a broad range of options for the optimal use of our resources, including the pursuit of non-nicotinic opportunities. In the coming months, Targacept will be continuing to carefully evaluate those portfolio options that we believe have the potential both to make a significant difference in patients’ lives and provide meaningful upside for our stakeholders. We will be holding a conference call in conjunction with our quarterly earnings release on August 6, 2014.”
About the Trial
The Phase 2b study was a double blind,
placebo controlled, randomized, parallel group trial conducted at 119
sites in the United States and involved 768 randomized patients with
OAB. The study’s co-primary endpoints were 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 trial included a
three- or five-week screening period, followed by a 12-week treatment
period during which patients received 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
two-week follow-up period.
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Forward-Looking Statements
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“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: 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. 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.
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