— Once-Daily, Oral Product Candidate
Demonstrated Antipsychotic Efficacy Statistically Superior to
Placebo and Similar to Olanzapine in ENLIGHTEN-1 Study —
— Management to Hold Conference Call Today at
4:30 p.m. ET —
Alkermes plc (NASDAQ: ALKS) today announced positive preliminary
topline results from ENLIGHTEN-1, the first of two key phase 3
studies in the ENLIGHTEN clinical development program for ALKS
3831, an investigational, novel, once-daily, oral atypical
antipsychotic drug candidate for the treatment of schizophrenia.
ENLIGHTEN-1 was a multinational, double-blind, randomized, phase 3
study that evaluated the antipsychotic efficacy, safety and
tolerability of ALKS 3831 compared to placebo over four weeks in
403 patients experiencing an acute exacerbation of schizophrenia.
The study also included a comparator arm of olanzapine, an
established atypical antipsychotic agent with proven efficacy. The
study met the prespecified primary endpoint, with ALKS 3831
demonstrating statistically significant reductions from baseline in
Positive and Negative Syndrome Scale (PANSS) scores compared to
placebo (p<0.001). Data from the study also showed that
olanzapine achieved similar improvements from baseline PANSS
scores, compared to placebo (p=0.004). The study also met its key
secondary endpoint of improvement on the Clinical Global Impression
– Severity (CGI-S) scale for ALKS 3831 versus placebo (p=0.002).
ALKS 3831 is designed to provide the strong antipsychotic efficacy
of olanzapine and a differentiated safety profile with favorable
weight and metabolic properties.
“The positive results of ENLIGHTEN-1 provide clear evidence of
the safety, tolerability and antipsychotic efficacy of ALKS 3831 in
a large, randomized registration trial,” said Elliot Ehrich, M.D.,
Executive Vice President of Research and Development at Alkermes.
“The results of this phase 3 study also provide additional evidence
of the antipsychotic properties of ALKS 3831 relative to
olanzapine, an agent well known to clinicians. We look forward to
completing our analysis of this large study and presenting the data
at a future medical meeting.”
“Many physicians recognize the powerful efficacy profile of
olanzapine, but are hesitant to prescribe it given the severe
weight gain and metabolic side effects commonly associated with its
use,” said Christoph Correll, M.D., Professor of Psychiatry and
Molecular Medicine at Hofstra Northwell School of Medicine. “A new
antipsychotic with robust efficacy and a favorable weight and
metabolic profile compared to olanzapine would be a welcome
addition to the schizophrenia treatment landscape. This study
confirms a key element of this profile, with a clear demonstration
of efficacy in a large, well-conducted clinical trial.”
Overall, 91% of patients who received ALKS 3831 completed the
study, compared to 89% of patients who received olanzapine and 83%
of patients who received placebo. The most common adverse events
for both the ALKS 3831 and olanzapine treatment groups were weight
gain, somnolence and dry mouth.
Alkermes will present comprehensive data from the ENLIGHTEN-1
study at an upcoming medical meeting and submit the results for
publication in a peer-reviewed journal. ENLIGHTEN-2, a six-month
phase 3 study evaluating the weight gain profile of olanzapine
compared to ALKS 3831, is ongoing with data expected in 2018.
About the ENLIGHTEN-1
StudyENLIGHTEN-1 was a multinational, double-blind,
randomized, phase 3 study that evaluated the antipsychotic
efficacy, safety and tolerability of ALKS 3831 compared to placebo
over four weeks in patients experiencing an acute exacerbation of
schizophrenia. The study also included a comparator arm of
olanzapine, an established atypical antipsychotic agent with proven
efficacy but also metabolic liabilities, including significant
weight gain.1 The trial included adult patients who met the
Diagnostic and Statistical Manual of Mental Disorders – Fifth
Edition criteria for schizophrenia, and had a PANSS score of 80 or
higher at study baseline.
A total of 403 patients were randomized in a 1:1:1 manner to
receive once-daily, oral tablets of ALKS 3831, olanzapine or
placebo for four weeks. Patients randomized to the ALKS 3831
treatment group received a bilayer fixed-dose tablet of 10 mg
samidorphan co-formulated with either 10 or 20 mg of olanzapine.
Patients randomized to the olanzapine treatment group received
either 10 or 20 mg of olanzapine. The primary efficacy endpoint of
the study was the mean change from baseline at Week 4 in PANSS
total score for ALKS 3831 compared to placebo, using a Mixed Model
with Repeated Measurements (MMRM) model. The key secondary endpoint
of the study was change from baseline in the CGI-S score at Week
4.
All participants who completed the double-blind portion of the
study were eligible to continue in an open-label, long-term safety
study and receive ALKS 3831 for an additional 12 months. The
objective of the extension phase of the study is to assess the
long-term safety, tolerability and durability of effect of ALKS
3831.
Conference CallAlkermes will
host a conference call today, June 29, 2017, at 4:30 p.m. ET (9:30
p.m. BST), to discuss these topline results. The conference call
may be accessed by dialing +1 888 424 8151 for U.S. callers and +1
847 585 4422 for international callers. The conference call ID
number is 6037988. The conference call will also be webcast on the
Investors section of Alkermes’ website at www.alkermes.com. The
webcast will be archived on the Investors section of the Alkermes
website for at least 90 days.
About the ENLIGHTEN Clinical
Development ProgramThe ENLIGHTEN clinical development
program for ALKS 3831 is comprised of two key studies: a study
evaluating the antipsychotic efficacy of ALKS 3831 compared to
placebo over four weeks and a study assessing weight gain with ALKS
3831 compared to olanzapine in patients with schizophrenia over six
months. The program also includes supportive studies to evaluate
the pharmacokinetic and metabolic profile of ALKS 3831, the effect
on body weight of ALKS 3831 in young adult patients early in their
illness, and long-term safety.
About ALKS 3831ALKS 3831 is
a proprietary, investigational medicine designed as a
broad-spectrum antipsychotic for the treatment of schizophrenia.
ALKS 3831 is composed of samidorphan, a novel, new molecular entity
co-formulated with the established antipsychotic agent, olanzapine,
in a single bilayer tablet.
Weight gain is a common and clinically relevant metabolic side
effect of atypical antipsychotic medications, and olanzapine,
commercially available as ZYPREXA®, has one of the highest
incidences and greatest amounts of weight gain among the widely
prescribed products in this class of drugs.1 ALKS 3831 is designed
to provide the strong antipsychotic efficacy of olanzapine and a
differentiated safety profile with favorable weight and metabolic
properties.
About
SchizophreniaSchizophrenia is a chronic, severe and
disabling brain disorder. The disease is marked by positive
symptoms (hallucinations and delusions) and negative symptoms
(depression, blunted emotions and social withdrawal), as well as by
disorganized thinking. An estimated 2.4 million American adults
have schizophrenia,2 with men and women affected equally.
About AlkermesAlkermes
plc is a fully integrated, global biopharmaceutical company
developing innovative medicines for the treatment of central
nervous system (CNS) diseases. The company has a diversified
commercial product portfolio and a substantial clinical pipeline of
product candidates for chronic diseases that include schizophrenia,
depression, addiction and multiple sclerosis. Headquartered in
Dublin, Ireland, Alkermes plc has an R&D center in Waltham,
Massachusetts; a research and manufacturing facility in Athlone,
Ireland; and a manufacturing facility in Wilmington, Ohio. For more
information, please visit Alkermes’ website
at www.alkermes.com.
Note Regarding Forward-Looking
StatementsCertain statements set forth in this press
release constitute “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not limited to, statements concerning: the
timing of receipt and reporting of the phase 1 metabolic and
ENLIGHTEN-2 study results; and the therapeutic value, development
plans and commercial potential of ALKS 3831. 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 expressed or implied 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 3831 will be predictive of future
clinical study results; whether the ENLIGHTEN-2 study for ALKS 3831
will be completed on time or at all; potential changes in cost,
scope and duration of the ALKS 3831 clinical development program;
whether ALKS 3831 could be shown ineffective or unsafe during
clinical studies; and those risks and uncertainties described under
the heading “Risk Factors” in the company’s Annual Report on Form
10-K for the year ended Dec. 31, 2016 and Quarterly Report on Form
10-Q for the quarter ended Mar. 31, 2017 and in subsequent filings
made by the company with the U.S. Securities and Exchange
Commission (SEC), which are available on the SEC’s website at
www.sec.gov. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release.
ZYPREXA® is a registered trademark of Eli Lilly &
Company.
1Komossa, K. et al. Olanzapine versus other atypical
antipsychotics for schizophrenia. Cochrane Database of Systematic
Reviews. 2010, Issue 3. Art. No.: CD006654.
2National Institutes of Health. Schizophrenia. Accessed on June
29, 2017 from
http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.
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Alkermes plcFor Investors:Eva Stroynowski, +1
781-609-6823orSandy Coombs, +1 781-609-6377orFor Media:Jennifer
Snyder, +1 781-609-6166
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