Adamas Announces First Patient Enrolled in Phase 3 Trial of ADS-5102 in Multiple Sclerosis Patients with Walking Impairment
April 03 2018 - 9:00AM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the
first patient has been enrolled in its pivotal Phase 3 clinical
trial of ADS-5102 (amantadine) extended release capsules in
multiple sclerosis (MS) patients with walking impairment. The
three-arm, multi-center, randomized, double-blind,
placebo-controlled study is expected to enroll up to 540 MS
patients with walking impairment in the United States.
“Initiating this Phase 3 study of ADS-5102 in MS
patients with walking impairment is a significant milestone for
Adamas, as it could potentially advance the approval of GOCOVRI
(amantadine) extended release capsules as a treatment for this MS
population,” said Rajiv Patni, M.D., Chief Medical Officer of
Adamas Pharmaceuticals, Inc. “The goal of the study is to confirm
the results of our Phase 2 proof-of-concept study and to
demonstrate the efficacy and safety of ADS-5102 using several
measures of walking in MS patients. This study deepens our
commitment to patients and has the potential to further validate
Adamas’ unique approach to drug development using time-dependent
biology.”
“Approximately half of MS patients become
dependent on some form of walking aid after 15 years due to their
underlying disease,” said Aaron Miller, M.D., Medical Director of
the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at
the Icahn School of Medicine at Mount Sinai in New York and a
member of the steering committee for the trial. “There is a
significant unmet medical need for additional therapies to treat
impaired mobility in MS as the current approved treatment option,
for this critically important function, is demonstrated to not be
effective for a majority of patients.”
The Phase 3 trial is based on the positive Phase
2 proof-of-concept data of ADS-5102 in MS patients with walking
impairment. The study found a statistically significant 17 percent
improvement in walking speed from baseline and that a greater
proportion of ADS-5102-treated patients experienced at least a 20
percent improvement in walking speed from baseline compared to
placebo-treated patients.
About the StudyThe study is a
three-arm, multi-center, randomized, placebo-controlled,
double-blind, parallel-group study of ADS-5102 in 540 patients with
MS who have walking impairment in the United States. The primary
objective will be to evaluate the efficacy of a once-daily 274 mg
dose of ADS-5102 administered at bedtime in MS patients with
walking impairment as measured by the Timed 25-foot Walk (T25FW,
feet/second) at Week 12. Secondary objectives are to evaluate the
efficacy of 274 mg ADS-5102 in MS patients with walking impairment
as measured by the Timed Up and Go (TUG) test, and the 2-Minute
Walk Test (2MWT) at Week 12; as well as to evaluate the efficacy of
a 137 mg dose of ADS-5102, administered once-daily at bedtime, in
MS patients with walking impairment as measured by the T25FW, the
TUG test, and the 2MWT at Week 12.
See www.clinicaltrials.gov for further
information (NCT03436199).
About Multiple Sclerosis and Walking
Impairmenti Multiple sclerosis (MS)
is a chronic autoimmune-mediated disorder and manifests as
unpredictable symptoms that can vary in severity and tend to
progress over years, in some cases to near total disability.
Walking, which depends on the coordinated functioning of multiple
CNS motor and sensory systems, is frequently impaired in MS and
affects a majority of the approximately 400,000 MS patients in the
United States. Walking impairment in MS patients remains an area of
high unmet need, as there is only one approved product on the
market for this indication.
About ADS-5102ADS-5102 is a
high-dose amantadine taken once-daily at bedtime, which delivers
consistently high levels of amantadine upon walking and throughout
the day. ADS-5102 was previously approved by the U.S. Food and Drug
Administration (FDA) under the trade name GOCOVRI™ (amantadine)
extended release capsules for the treatment of dyskinesia in
patients with Parkinson’s disease receiving levodopa-based therapy,
with or without concomitant dopaminergic medications. GOCOVRI is
not FDA-approved for the treatment of walking impairment in
multiple sclerosis patients.
About Adamas Pharmaceuticals, Inc.Adamas
is using its deep understanding of time-dependent biology to
redefine the treatment experience for patients suffering from
chronic neurological diseases. The company is building upon the
commercial launch of GOCOVRI™ (amantadine) extended release
capsules (previously ADS-5102), the first and only FDA-approved
medicine for the treatment of dyskinesia in patients with
Parkinson’s disease, with a pipeline of differentiated
investigational programs, which includes: ADS-5102 in development
for the treatment of multiple sclerosis walking impairment; and
ADS-4101, a high-dose, modified release lacosamide in development
for the treatment of partial onset seizures in patients with
epilepsy. Adamas’ goal is to create and commercialize a new
generation of neurological medicines intended to lessen the burden
of disease on patients, caregivers and society.
For more information about Adamas and its unique
approach to developing medicines based on time-dependent biology,
please visit www.adamaspharma.com.
Forward-looking Statements
Statements contained in this press release regarding matters that
may occur in the future are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including but not limited to, statements contained in this press
release regarding the potential clinical benefits of GOCOVRI or
about Adamas’ ongoing or planned clinical development programs
because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. For a description of
risks and uncertainties that could cause actual results to differ
from those expressed in forward-looking statements, including risks
relating to Adamas' research, clinical, development and commercial
activities relating to GOCOVRI and ADS-5102, the regulatory and
competitive environment and Adamas' business in general, see
Adamas’ Annual Report on Form 10-K filed with the Securities and
Exchange Commission on February 22, 2018, particularly under the
caption “Risk Factors.” Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date of this release. Adamas undertakes no obligation to
update any forward-looking statement in this press release.
_________________________i Sutliff 2010
Contact:
Media:
Terri Clevenger
Continuum Health Communications
203-227-0209
tclevenger@continuumhealthcom.com
Investors:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com
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