WINSTON-SALEM, N.C.--(BUSINESS WIRE)--Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of two clinical studies of TC-5619, a Phase 2b study evaluating the product candidate as a treatment for negative symptoms and cognitive dysfunction in schizophrenia and a Phase 2 study evaluating the product candidate in adults as a treatment for attention deficit/hyperactivity disorder (ADHD), inattentive-predominant. TC-5619 is a highly selective modulator of the alpha7 neuronal nicotinic receptor.
“Our prior clinical findings with TC-5619, particularly the improvements in negative symptomatology in a study in schizophrenia patients and on both investigator-rated and subject-rated scales in the inattentive-predominant dataset in a study in adults with ADHD, have us enthusiastic about its potential in both areas,” said Geoffrey C. Dunbar, M.D., Targacept’s Senior Vice President, Clinical Development and Regulatory Affairs and Chief Medical Officer.
“Currently available treatment options are not well suited for ADHD patients whose challenges are predominantly on the inattentiveness side,” said Paul Newhouse, M.D., Professor of Psychiatry and Director, Center for Cognitive Medicine, Department of Psychiatry at the Vanderbilt Kennedy Center. “There is a compelling need for mechanistically novel, well-tolerated medicines to treat these patients.”
About the Phase 2b Study in Patients with Schizophrenia
The Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial planned to be conducted approximately 25% at sites in the United States and approximately 75% at sites in Eastern Europe. The primary outcome measure is the Scale for the Assessment of Negative Symptoms (SANS). Key secondary outcome measures include the CogState Schizophrenia Battery (composite score), a computerized cognitive test battery, and the University of San Diego Performance-Based Skills Assessment, brief version. The study is designed to enroll approximately 450 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic. The study includes a four-week screening period, followed by a 24-week treatment period during which patients receive either one of two doses of TC-5619 (5mg or 50mg) or placebo daily, randomized in a ratio of 2:1:1 (placebo, low dose, high dose).
About Negative Symptoms and Cognitive Dysfunction in Schizophrenia
Schizophrenia is a chronic, severe and disabling form of psychosis. In addition to positive symptoms such as delusions, hallucinations and disorganized speech, recognized features of the disease include negative symptoms, such as anhedonia, affective flattening, avolition, social withdrawal and alogia, and impairment in cognitive function, such as executive function, attention, vigilance, memory and learning. These negative symptoms and cognitive impairments play a primary role in the inability of many schizophrenic patients to function normally. The market research firm Decision Resources has estimated there were approximately 4.6 million people with schizophrenia in the world’s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan) in 2010 and that about 80% of persons with schizophrenia are cognitively impaired. Estimates as to the prevalence of schizophrenia patients who suffer from negative symptoms vary. There is currently no drug approved in the United States or Europe specifically for either negative symptoms or cognitive dysfunction in schizophrenia.
About the Phase 2 Study in Adults with Inattentive-Predominant ADHD
The Phase 2 study is a double blind, placebo controlled, randomized, parallel group trial planned to be conducted solely at sites in the United States. The primary outcome measure is the Inattention subscale of the Conners’ Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV). The study is designed to enroll approximately 80 adults with inattentive-predominant ADHD. The study design includes a four-week screening period, followed by a four-week treatment period during which patients receive either one of two doses of TC-5619 (5mg or 25mg) or placebo daily, randomized in a ratio of 2:1:1 (placebo, low dose, high dose). The study is powered to demonstrate a statistically significant difference between TC-5619 and placebo on the primary outcome measure using a one-sided test and a significance level of 10% (p ˂ 0.10).
About Inattentive-Predominant ADHD
The principal characteristics of ADHD, a condition that develops during childhood, are inattention, hyperactivity and impulsivity. The Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) segregates ADHD into predominantly inattentive, predominantly hyperactive/impulsive, and combined, a diagnosis that is based on an assessment of the respective numbers of inattention and hyperactivity/impulsivity criteria met by a patient. Decision Resources estimated that more than 60% of pediatric ADHD cases in the world’s seven major pharmaceutical markets in 2010 were inattentive-predominant, with an estimated total ADHD prevalence of approximately 23.5 million adults and 23.8 million children and adolescents.
About Targacept
Targacept is developing a diverse pipeline of innovative NNR Therapeutics(TM) for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, a unique class of proteins that regulate vital biological functions that are impaired in various disease states. Targacept’s lead program, TC-5214, is being co-developed with AstraZeneca and is in Phase 3 clinical trials as an adjunct treatment for major depressive disorder. Targacept leverages its scientific leadership and proprietary drug discovery platform Pentad(TM) to generate novel small molecule product candidates to fuel its pipeline and attract significant collaborations with global pharmaceutical companies. For more information, please visit www.targacept.com.
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Forward-Looking Statements
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 progress or scope of development of TC-5619, such as the target indication(s) for development or the number of patients or geographic allocation of study sites for each of the two ongoing clinical trials; the medical benefits that may be derived from TC-5619; the competitive position of TC-5619 or the commercial opportunity in negative symptoms in schizophrenia, cognitive dysfunction in schizophrenia or inattentive-predominant ADHD; 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 risks and uncertainties relating to: the conduct and results of the ongoing clinical trials of TC-5619 in schizophrenia patients and adult inattentive-predominant ADHD patients and other non-clinical studies and assessments of TC-5619, including the performance of third parties engaged to execute such trials, studies and assessments, delays resulting from any changes to the applicable protocols, disparate enrollment rates among study sites and difficulties or delays in the completion of patient enrollment or data analysis; whether positive findings from completed clinical trials of TC-5619 will be replicated in the ongoing or any future clinical trials; and whether FDA or foreign regulatory authorities will determine the designs and endpoints of clinical trials of TC-5619 to be sufficient to support approval of TC-5619 for the treatment of negative symptoms in schizophrenia, cognitive dysfunction in schizophrenia or inattentive-predominant ADHD; and the timing and success of submission, acceptance and approval of any regulatory filings for TC-5619. 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.
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