Alkermes Announces Positive Results from Phase 2 Clinical Study of ALKS 5461 for Major Depressive Disorder
Alkermes
plc (NASDAQ: ALKS) today announced positive preliminary topline
results from a phase 2 study of ALKS 5461, its novel drug compound for
major depressive disorder (MDD) in patients who have an inadequate
response to standard therapies for clinical depression. ALKS 5461
reflects a new approach to the treatment of MDD based on modulation of
opioid receptors in the brain and is designed as a non-addictive, oral,
once-daily medicine. Data from the study showed that ALKS 5461
significantly reduced depressive symptoms across a range of standard
measures including the study’s primary outcome measure, the Hamilton
Depression Rating Scale (HAM-D17) (p=0.026), the Montgomery–Åsberg
Depression Rating Scale (MADRS) (p=0.004) and the Clinical Global
Impression – Severity Scale (CGI-S) (p=0.035). ALKS 5461 was generally
well tolerated. Based on these results, as well as the positive phase
1/2 results previously reported, Alkermes plans to request a meeting
with the U.S. Food and Drug Administration (FDA) and advance ALKS 5461
into a pivotal development program. Data from this phase 2 study will be
presented at the 53rd Annual New Clinical Drug Evaluation
Unit (NCDEU) Meeting in Hollywood, Fla., May 28-31, 2013.
“The improvements in depressive symptoms observed in patients treated
with ALKS 5461 in this study were clinically meaningful and among the
most robust I have seen in a phase 2 study for depression in the past
two decades. This promising candidate could provide a valuable new
treatment approach for this serious and chronic disease,” stated
Maurizio Fava, M.D., Director of the Depression Clinical and Research
Program at Massachusetts General Hospital and Slater Family Professor of
Psychiatry at Harvard Medical School. “There is significant unmet
medical need for novel treatments with new mechanisms of action for
depression, as many patients do not adequately respond to existing
pharmacological therapies.”
The phase 2, randomized, double-blind, multicenter, placebo-controlled
study assessed the efficacy and safety of two doses of ALKS 5461 when
administered once daily for four weeks as adjunctive treatment in 142
patients with MDD who had an inadequate response to a stable dose of
either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin-norepinephrine reuptake inhibitor (SNRI). Patients received
one of two dosing regimens of oral ALKS 5461 or placebo for a treatment
period of four weeks. The study utilized a sequential parallel
comparison design, a design developed ten years ago by Drs. Fava and
Schoenfeld at Massachusetts General Hospital and now widely utilized in
clinical trials. The primary endpoint of the study was the change from
baseline in depressive symptoms over a four-week treatment period, as
measured by the HAM-D17. Secondary endpoints included additional
analyses of patient responses based on HAM-D17, MADRS and CGI-S scores.
“ALKS 5461 has the potential to be a novel therapy with a unique
mechanism of action for depression and validates our expertise with
opioid modulators,” stated Elliot Ehrich, M.D., Chief Medical Officer of
Alkermes. “Based on the strength of these data, as well as the positive
results seen in the prior clinical study, we will move forward rapidly
to meet with the FDA and initiate a pivotal development program with a
goal of bringing this important new medication to patients with MDD.”
About ALKS 5461
ALKS 5461 is the combination of ALKS 33 and buprenorphine and is
designed to be a non-addictive opioid modulator. ALKS 33 is an oral
opioid modulator that builds on Alkermes’ scientific expertise in opioid
biology and pharmacology, as well as the company’s clinical and
commercial knowledge in the field of addiction and central nervous
system disorders.
About MDD
According to the DSM-IV-TR® (Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision), major depressive disorder (MDD) is a condition in which
patients exhibit depressive symptoms, such as a depressed mood or a loss
of interest or pleasure in daily activities consistently for at least a
two-week period, and demonstrate impaired social, occupational,
educational or other important functioning. An estimated 16.1 million
people in the U.S. suffer from MDD in a given year,1,2 the
majority of whom may not adequately respond to initial antidepressant
therapy.3
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company
that applies its scientific expertise and proprietary technologies to
develop innovative medicines that improve patient outcomes. The company
has a diversified portfolio of more than 20 commercial drug products and
a substantial clinical pipeline of product candidates that address
central nervous system (CNS) disorders such as addiction, schizophrenia
and depression. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and manufacturing facilities in
Gainesville, Georgia and Wilmington, Ohio. For more information, please
visit Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including, but not limited to
statements concerning: the therapeutic value of ALKS 5461; the clinical
development of ALKS 5461, including the results of meetings with
regulatory authorities and the product’s clinical development timeline;
and the timing of the company’s planned presentation of phase 2 data of
ALKS 5461. You are cautioned that forward-looking statements are
inherently uncertain. Although the company believes that such statements
are based on reasonable assumptions within the bounds of its knowledge
of its business and operations, the forward-looking statements are
neither promises nor guarantees and they are necessarily subject to a
high degree of uncertainty and risk. Actual performance and results may
differ materially from those projected or suggested in the
forward-looking statements due to various risks and uncertainties. These
risks and uncertainties include, among others: whether preclinical and
clinical results for ALKS 5461 will be predictive of future clinical
study results; whether the company will initiate a pivotal development
program for ALKS 5461; whether future clinical trials for ALKS 5461 will
be completed on time or at all; potential changes in cost, scope and
duration of the ALKS 5461 clinical development program; whether ALKS
5461 could be shown ineffective or unsafe during clinical studies, and
whether the company will not be permitted by regulatory authorities to
undertake new or additional clinical studies for ALKS 5461; and those
risks described in the Alkermes plc Annual Report on Form 10-K for the
year ended March 31, 2012, and in other filings made by the company with
the U.S. Securities and Exchange Commission (SEC), which are available
at the SEC’s website at www.sec.gov.
The information contained in this press release is provided by the
company as of the date hereof, and, except as required by law, the
company disclaims any intention or responsibility for updating any
forward-looking information contained in this press release.
DSM-IV-TR® is a registered trademark of the
American Psychiatric Association.
1 Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence,
severity, and comorbidity of twelve-month DSM-IV disorders in the
National Comorbidity Survey Replication (NCS-R). Archives of General
Psychiatry, 2005 Jun; 62 (6): 617-27.
2 U.S. Census.
3 Rush AJ et al (2007) Am J. Psychiatry 163:11, pp.
1905-1917 (STAR*D Study).
