–– Novel, Oral Product Candidate Provided Monomethyl Fumarate Exposures Comparable to TECFIDERA®, With Favorable Gastrointestinal Tolerability ––
–– Company Plans to
“The results from this study demonstrated ALKS 8700 converts efficiently
into MMF after oral administration with the potential to offer improved
GI tolerability for patients with MS,” said
Phase 1 Study Design and Results
The three-part, randomized, double-blind phase 1 study was conducted in 104 healthy subjects. Part 1 was a single-ascending-dose, placebo-controlled design in 56 subjects to evaluate the safety, tolerability and PK of a range of single doses of ALKS 8700, and determine a dose that would provide MMF exposure comparable to 240 mg TECFIDERA, to be used in Part 2. Part 2 was a two-treatment, two-period crossover design in 16 subjects that compared the PK and tolerability of a single dose of ALKS 8700, 240 mg TECFIDERA or placebo. Part 3 included 32 subjects and evaluated PK of extended-release formulations of ALKS 8700.
In Part 1, doses of ALKS 8700 ranging from 49 mg to 980 mg were
evaluated. ALKS 8700 was rapidly converted to MMF, a dose-exposure
relationship was observed, with higher MMF exposure associated with
increasing ALKS 8700 dose levels, and a dose of ALKS 8700 providing MMF
plasma exposure comparable to 240 mg TECFIDERA was identified for Part
2. In Part 2, subjects on active drug received either the selected dose
of ALKS 8700 from Part 1 or 240 mg TECFIDERA, followed by the other
agent on a subsequent day, thereby enabling a crossover comparison of PK
and tolerability within the same subjects. In this part of the study,
subjects who received ALKS 8700 demonstrated less variability in MMF
exposure than subjects who received TECFIDERA, with a significantly
lower maximum plasma concentration (Cmax). The percentage of subjects
with GI-related AEs was lower with ALKS 8700 (8.3%) compared to
TECFIDERA (41.7%). In Part 3, the PK data of the extended-release
formulations of ALKS 8700 provided new insights into approaches for
once-daily dosing options, which
Throughout the study, all dose levels of ALKS 8700 were generally well
tolerated. The most common AEs were flushing and GI-related; all AEs
were mild or moderate in severity. No serious AEs or discontinuations
due to AEs were observed for ALKS 8700 in the study.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) molecule in development for the treatment 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 therapeutic value, development
plans and commercial potential of ALKS 8700. 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 early
clinical results for ALKS 8700 will be predictive of future clinical
study results; whether future clinical trials for ALKS 8700 will be
initiated or 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
1 National
2
Source:
Alkermes plc
For Investors:
Rebecca Peterson, +1-781-609-6378
or
For
Media:
Jennifer Snyder, +1-781-609-6166