–– Data From More Than 570 Patients in Ongoing Long-Term Safety Study
of ALKS 8700 Demonstrate Low Rates of Discontinuation During Initial
Three Months of Treatment ––
DUBLIN--(BUSINESS WIRE)--Oct. 27, 2017--
Alkermes
plc (NASDAQ: ALKS) today presented safety and gastrointestinal (GI)
tolerability data from EVOLVE-MS-1, an ongoing open-label, two-year
phase 3 safety study for ALKS 8700, a novel, oral monomethyl fumarate
(MMF) prodrug candidate in development for the treatment of relapsing
forms of multiple sclerosis (MS). Interim data from more than 570
patients at one and three months of treatment with ALKS 8700 were
presented at MSParis2017, the 7th Joint Meeting of the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) and the Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) in Paris, France.
Safety data from the first month of the EVOLVE-MS-1 study (N=580) showed
that treatment with ALKS 8700 was associated with low rates of GI
adverse events (AEs) leading to discontinuation (0.5%) and no occurrence
of serious GI AEs. The most common AEs during the first month of
treatment with ALKS 8700 were flushing (31.7%), pruritus (7.4%) and
diarrhea (6.6%). Data from the initial three months of treatment in the
study (N=574) support and extend the safety profile for ALKS 8700, with
2.3% of patients reporting serious AEs, and 3.7% experiencing AEs that
led to study discontinuation.
“When choosing a treatment regimen for a chronic disease like MS,
patients and their healthcare providers must weigh multiple factors,
including efficacy, safety, tolerability and convenience. Fumarate
therapy is recognized in the clinical community as an efficacious option
for patients with MS, but it is also known to be associated with GI side
effects that may lead to treatment interruption or discontinuation,
particularly in the first few weeks following treatment initiation,”
said Robert Naismith, M.D., Associate Professor of Neurology, Washington
University School of Medicine in St. Louis. “A new treatment option that
provides therapeutic levels of fumarate therapy with a differentiated
safety profile would be a valuable and welcomed option for members of
the MS community.”
“We are encouraged by the safety data presented today for ALKS 8700, a
MMF prodrug with distinct physical-chemical properties, as these interim
results reinforce the safety and GI tolerability profile we set out to
develop in a potential new oral therapy for the treatment of MS,” said
Elliot Ehrich, M.D., Executive Vice President of Research and
Development at Alkermes. “We are committed to bringing this potential
valuable new treatment to patients and providers and remain on track to
announce initial data from the GI tolerability study comparing ALKS 8700
to TECFIDERA, and to submit the planned New Drug Application for ALKS
8700 in 2018.”
A poster on the data, titled “EVOLVE-MS-1: A Phase 3, Open-Label,
Long-Term Safety Study of ALKS 8700 in Relapsing-Remitting Multiple
Sclerosis,” was presented on Friday, Oct. 27 at 3:30 p.m. CEST (9:30
a.m. ET). For more information, including a complete list of abstract
titles, please visit the MSParis2017 website at https://www.ectrims-congress.eu/2017.html
About the EVOLVE-MS Clinical Development Program
The key components of the EVOLVE-MS (Endeavoring
to Advance Treatment for Patients Living
with Multiple Sclerosis) clinical
development program of ALKS 8700 include a two-year safety study and
pharmacokinetic bridging studies comparing ALKS 8700 and TECFIDERA®.
In addition, the program includes an elective head-to-head study
comparing the GI tolerability of ALKS 8700 and TECFIDERA.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF)
prodrug candidate in development for the treatment of relapsing forms of
multiple sclerosis (MS). ALKS 8700 is designed to rapidly and
efficiently convert to MMF in the body and to offer differentiated
features as compared to the currently marketed dimethyl fumarate,
TECFIDERA®.
About Multiple Sclerosis
Multiple sclerosis (MS) is an unpredictable, often disabling disease of
the central nervous system (CNS), which interrupts the flow of
information within the brain, and between the brain and body.1 MS
symptoms can vary over time and from person to person. Symptoms may
include extreme fatigue, impaired vision, problems with balance and
walking, numbness or pain and other sensory changes, bladder and bowel
symptoms, tremors, problems with memory and concentration and mood
changes, among others.1 Approximately 400,000 individuals in
the U.S. and 2.5 million people worldwide have MS, and most are
diagnosed between the ages of 15 and 50.2
About Alkermes
Alkermes 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 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, as amended, including, but not
limited to, statements concerning: the continued clinical development
and therapeutic value of ALKS 8700 for the treatment of relapsing forms
of MS, the adequacy of the EVOLVE-MS development program for ALKS 8700
to serve as the basis for a new drug application (NDA), the commercial
potential of ALKS 8700, and the timing of the submission of the NDA to
the U.S. Food and Drug Administration (FDA) for ALKS 8700. The company
cautions 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 the results from the
head-to-head study to evaluate the GI tolerability of ALKS 8700 compared
to TECFIDERA will show that ALKS 8700 has favorable GI tolerability;
whether preclinical and early clinical results for ALKS 8700 will be
predictive of future clinical study results; whether clinical trials for
ALKS 8700 will be completed on time or at all; changes in the cost,
scope and duration of the ALKS 8700 clinical trials; whether ALKS 8700
could be shown ineffective or unsafe during clinical studies, and
whether, in such instances, Alkermes may not be permitted by regulatory
authorities to undertake new or additional clinical studies of ALKS
8700; whether regulatory submissions for ALKS 8700 will be submitted on
time or at all; whether adverse decisions by regulatory authorities
occur; whether the pharmacokinetic, phase 3 and other studies conducted
for ALKS 8700 will meet the FDA’s requirements; and those risks
described in the Alkermes plc Annual Report on Form 10-K for the fiscal
year ended Dec. 31, 2016, and Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2017, June 30, 2017 and Sept. 30, 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.
TECFIDERA® is a registered trademark of Biogen MA Inc.
1 National Multiple Sclerosis Society. Multiple Sclerosis:
Just the Facts. Accessed from http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Just-the-Facts.pdf
on Oct. 26, 2017.
2 Multiple Sclerosis Association of
America. MS Overview. Accessed from http://mymsaa.org/ms-information/overview/who-gets-ms/
on Oct. 26, 2017.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171027005055/en/
Source: Alkermes plc
Alkermes Contacts:
For Investors:
Eva
Stroynowski, +1 781-609-6823
or
Sandy Coombs, +1 781-609-6377
or
For
Media:
Jennifer Snyder, +1 781-609-6166
