Winston-Salem, North Carolina Apr 23, 2009
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), today announced the initiation of a Phase 2 exploratory study of TC-5214, a nicotinic channel blocker, as an augmentation therapy for resistant hypertension. TC-5214 is also being studied in an ongoing Phase 2b clinical trial as an augmentation therapy for major depressive disorder.
“We believe the unique profile of TC-5214 makes it a promising product candidate as an augmentation therapy to existing medications to help address the unmet need for patients with resistant hypertension,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. “In addition, we remain enthusiastic about the therapeutic potential of TC-5214 as an augmentation therapy for major depressive disorder and expect to complete our ongoing Phase 2b trial in mid 2009.”
It is well established that nicotinic channel blockers that inhibit activity of neuronal nicotinic receptors (NNRs) in the peripheral nervous system can have anti-hypertensive effects. However, these agents activate compensatory mechanisms in the body that, over time, can offset the intended beneficial effects. A number of currently available medications are known to block these mechanisms, but these medications alone are not sufficient to control blood pressure for treatment resistant patients. The use of a nicotinic channel blocker to augment existing medications may have the potential to achieve blood pressure targets for these patients.
Hypertension, or high blood pressure, leads to an increased risk for life threatening cardiovascular events such as heart attack, stroke and congestive heart failure. The American Heart Association estimates that hypertension affects about 73 million people in the United States age 20 and older. Resistant hypertension, also sometimes called refractory hypertension, occurs where high blood pressure is not returned to within normal ranges with the use of three anti-hypertensives from different drug classes, including a diuretic. Although the exact prevalence is unknown, it has been estimated that approximately 10 million patients in the United States are impacted by resistant hypertension.
“There is a great unmet medical need for novel drugs to augment existing therapies and improve clinical outcomes for the millions of patients who are not able to control their blood pressure. These individuals are at significant risk for serious cardiovascular events that often result in death or permanent disability,” said Dr. Carlos M. Ferrario, MD, FACC, the founder of the Hypertension and Vascular Disease Research Center at Wake Forest University School of Medicine. “The mechanistic rationale for TC-5214 is compelling for the treatment of resistant hypertension and I am excited to see it investigated in the clinic.”
The design for the double blind, placebo controlled Phase 2 exploratory study of TC-5214 provides for approximately 12 subjects with resistant hypertension to receive either a single escalating dose of TC-5214 or placebo once per week for four weeks and then a fixed daily dose of TC-5214 or placebo over the next two weeks. The trial is being conducted at Piedmont Medical Group in Winston-Salem, North Carolina.
About Targacept
Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics (TM), a new class of drugs for the treatment of central nervous system diseases and disorders. Targacept’s product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has clinical-stage product candidates in development for major depressive disorder, resistant hypertension, Alzheimer’s disease, attention deficit/hyperactivity disorder and cognitive dysfunction in schizophrenia, as well as multiple preclinical programs. Targacept also has a cognition-focused collaboration with AstraZeneca and a strategic alliance with GlaxoSmithKline. Targacept’s news releases are available on its website at www.targacept.com.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature constitute “forward-looking statements” made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the progress or scope of the research and development of TC-5214, such as the number of subjects to be enrolled in or the number of sites for Targacept’s Phase 2 study in resistant hypertension and the timing for completion of Targacept’s Phase 2b trial in major depressive disorder, the potential therapeutic benefits of TC-5214, including the ability of nicotinic channel blockers to achieve blood pressure targets in patients with resistant hypertension, or Targacept's plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including, without limitation, risks and uncertainties relating to: whether TC-5214 becomes subject in the future to a strategic alliance, collaboration, license or other arrangement and the terms of any such strategic alliance, collaboration, license or other arrangement; and the conduct and results of Targacept’s ongoing Phase 2b clinical trial of TC-5214 as an augmentation therapy for major depressive disorder, Targacept’s ongoing Phase 2 study of TC-5214 as an augmentation therapy for resistant hypertension and non-clinical studies and assessments of TC-5214, including the performance of third parties engaged to execute such trials, studies and assessments, delays resulting from any changes to the applicable protocols and difficulties or delays in the completion of subject enrollment or data analysis. These and other risks and uncertainties that may impact actual results are described in greater detail under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and in other filings that Targacept 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 statements in this release represent Targacept’s views only as of the date of this 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 (TM) is a trademark of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.
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Targacept Contacts:
Alan Musso, VP and CFO
Targacept, Inc.
Tel: (336) 480-2186
Email: alan.musso@targacept.com
Michelle Linn
Linnden Communications
Tel: (508) 362-3087
Email: linnmich@comcast.net