–– Safety and Gastrointestinal Tolerability Profile During Initial Three Months of ALKS 8700 Treatment in Ongoing Long-Term Safety Study to be Highlighted ––
“We designed ALKS 8700, a MMF prodrug with distinct physical-chemical
properties, to harness the efficacy of monomethyl fumarate with a
differentiated safety and tolerability profile,” said
-
Poster #708, “EVOLVE-MS-2: A Randomized, Double-Blind, Phase 3 Study
of the Gastrointestinal Tolerability of ALKS 8700 Versus Dimethyl
Fumarate in Relapsing-Remitting Multiple Sclerosis,” will describe the
study design, preliminary patient demographics and baseline
characteristics of an ongoing, elective head-to-head study evaluating
ALKS 8700 vs. TECFIDERA during Poster Session I,
Thursday, Oct. 26, 2017 , 3:30 –5:00 p.m. CEST . -
Poster #1170, “EVOLVE-MS-1: A Phase 3, Open-Label, Long-Term Safety
Study of ALKS 8700 in Relapsing-Remitting Multiple Sclerosis,” will
describe patient demographics, baseline characteristics, and safety
and GI tolerability data from the ongoing two-year, open-label safety
study of ALKS 8700 during Poster Session II,
Friday, Oct. 27, 2017 , 3:30 –5:00 p.m. CEST .
For more information, please visit the conference 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
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 and the commercial potential of 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,
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.
13, 2017.
2
View source version on businesswire.com: http://www.businesswire.com/news/home/20171016005166/en/
Source:
Alkermes Contacts:
For Investors:
Eva
Stroynowski, +1 781-609 6823
Sandy Coombs, +1 781-609-6377
or
For
Media:
Jennifer Snyder, +1 781-609-6166