Published: December 19, 2011
AstraZeneca and Targacept Announce Top-line Results from Second Phase 3 Study of TC-5214 as an Adjunct Treatment in Patients with Major Depressive Disorder
WINSTON-SALEM, N.C. - (BUSINESS WIRE) - AstraZeneca and Targacept, Inc. today announced top-line results from
the second of four RENAISSANCE Phase 3 studies investigating the
efficacy and tolerability of TC-5214 as an adjunct therapy to an
antidepressant in patients with major depressive disorder (MDD) who do
not respond adequately to initial antidepressant treatment. The study,
RENAISSANCE 2, did not meet its primary endpoint, change in the
Montgomery-Asberg Depression Rating Scale (MADRS) total score after
eight weeks of adjunct treatment with TC-5214 as compared to placebo.
These results follow the recent announcement of top-line results from
RENAISSANCE study 3, which also did not meet its primary endpoint. Both
RENAISSANCE 2 and RENAISSANCE 3 were flexible dose trials. The two
remaining efficacy studies in the RENAISSANCE Program for TC-5214 are
fixed dose trials. Top-line results for both fixed dose trials, as well
as for a long-term study designed primarily to evaluate safety, are
expected to be available in the first half of 2012.
TC-5214 was overall well tolerated in RENAISSANCE study 2 and showed an
adverse event profile generally consistent with prior clinical trials of
TC-5214. Analyses of the full data set from the RENAISSANCE study 2
remain ongoing.
Regulatory filing targets will be reviewed following results of the
remaining RENAISSANCE Program studies. A potential New Drug Application
filing in the United States is planned for the second half of 2012, with
a potential EU Marketing Authorization Application filing targeted for
2015.
About the Targacept and AstraZeneca Collaboration
In December 2009, AstraZeneca and Targacept signed a collaboration and
license agreement for the global development and commercialization of
TC-5214. The initial goal for the collaboration is to develop TC-5214 as
an adjunct treatment for MDD in patients with an inadequate response to
a selective serotonin reuptake inhibitor (SSRI) or
serotonin/norepinephrine reuptake inhibitor (SNRI). TC-5214 is also
being studied in a Phase 2b 'switch' monotherapy trial, known as the
EXPLORER study, in patients with MDD who do not respond adequately to
initial treatment with an SSRI or SNRI.
About MDD
MDD is characterized by one or more major depressive episodes without a
history of manic, mixed or hypomanic episodes. The essential feature of
a major depressive episode is a period of at least two weeks during
which there is depressed mood or the loss of interest or pleasure in
nearly all activities. In the large-scale STAR*D study sponsored by the
US National Institute of Mental Health between 2001 and 2006,
approximately 63 percent of patients with MDD did not achieve
study-defined remission with first-line treatment with the SSRI
citalopram hydrobromide.
About the RENAISSANCE Program (TC-5214)
The RENAISSANCE Program consists of five randomized, double-blind,
placebo controlled Phase 3 studies. In RENAISSANCE study
2, 1,320 patients with MDD were screened at 45 sites in the United
States (75% of evaluated patients) and 25 sites in India. Of the
patients screened, 710 initially received one of seven SSRIs or SNRIs on
an open label basis for eight weeks to determine the extent of
therapeutic response. At the end of the eight weeks, 319 patients who
did not respond adequately, based on predefined criteria, were
randomized into the double blind phase of the study and received either
a flexible dose of TC-5214 or placebo, twice daily, while continuing the
SSRI or SNRI therapy for an additional eight weeks. The dosage of
TC-5214 was initially 2 mg/day and could be increased at the discretion
of the investigator to 4 mg/day and 8 mg/day based on tolerability and
therapeutic response.
In addition to RENAISSANCE 2 and RENAISSANCE 3 (previously reported),
the RENAISSANCE Program includes two fixed dose studies (RENAISSANCE 4
and RENAISSANCE 5) designed to evaluate the efficacy and tolerability of
TC-5214 as an adjunct treatment to SSRI/SNRI therapy and RENAISSANCE 7,
a long-term study designed primarily to evaluate safety in which
patients receive a fixed dose of TC-5214 or placebo, plus a baseline
SSRI or SNRI, for one year.
About the Montgomery-Asberg Depression Rating Scale
The Montgomery-Asberg Depression Rating Scale (MADRS) is a commonly used
10-item questionnaire that psychiatrists employ to measure the severity
of depressive episodes in patients with mood disorders.
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, 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 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.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialization
of prescription medicines for gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious
disease. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.com
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 timing for
completion or availability of results from the remaining clinical trials
in the Phase 3 RENAISSANCE Program for TC-5214 or for submission or
approval of a New Drug Application (NDA) for TC-5214 in the United
States or a Marketing Authorization Application (MAA) for TC-5214 in the
European Union; the competitive position of or commercial opportunity
for TC-5214; 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: Targacept's dependence on the success of its collaboration
for TC-5214 with AstraZeneca; the control or significant influence that
AstraZeneca has over the development of TC-5214, including over the
decision to file an NDA or MAA for TC-5214; the conduct and results of
clinical trials and non-clinical studies and assessments of TC-5214,
including the performance of third parties engaged to execute such
trials, studies and assessments and difficulties or delays in data
analysis; whether positive findings from the completed Phase 2b clinical
trial of TC-5214 will be replicated in ongoing or any future clinical
trials; the timing and success of submission, acceptance and approval of
regulatory filings for TC-5214, including the discretion of the FDA in
determining whether to approve any NDA that may be filed for TC-5214;
and Targacept's ability to protect its intellectual property covering
TC-5214. These and other risks and uncertainties 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 Pentad are trademarks of Targacept, Inc. Any
other service marks, trademarks and trade names appearing in this press
release are the properties of their respective owners.
Targacept, Inc.
Alan Musso, 336-480-2186
SVP, Finance
and Administration and CFO
alan.musso@targacept.com
or
Linnden
Communications
Michelle Linn, 508-362-3087
linnmich@comcast.net
or
AstraZeneca
Media
Enquiries
Esra Erkal-Paler, +44 20 7604 8030 (24 hours)
or
Abigail
Baron, +44 20 7604 8034 (24 hours)
or
Isabelle Jouin, +44 20
7604 8031 (24 hours)
or
Investor Enquiries UK
Karl
Hård, +44 20 7604 8123
mob: +44 7789 654364
or
Nicklas
Westerholm, +44 20 7604 8124
mob: +44 7585 404950
or
Investor
Enquiries US
Ed Seage, +1-302-886-4065
mob: +1-302-373-1361
or
Jorgen
Winroth, +1-212-579-0506
mob: +1-917-612-4043
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