Adamas provides program update for ADS-5102 for multiple sclerosis patients with walking impairment
June 17 2020 - 4:01PM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases, today
announced the completion of its evaluation of ADS-5102 in multiple
sclerosis patients with walking impairment (MSW).
A comprehensive analysis of the INROADS Phase 3
data validated the top line results announced in December 2019 and
informed a revised target product profile reflecting the scale of
clinical benefit observed in the study. Additional patient,
physician, and payer research based on the revised profile
projected a limited commercial opportunity. Further engagement with
the U.S. Food and Drug Administration (FDA) to fully understand a
potential path to submission confirmed the need for an additional
pivotal Phase 3 confirmatory study. Based on these findings, Adamas
reconfirms it will not initiate further Phase 3 development in
MSW.
“As a patient focused company this was a
difficult decision, and I want to thank the patients, healthcare
professionals, and employees who contributed to this development
program. There remains a significant unmet need for this population
and we are committed to completing the open-label study and
publishing our data to benefit the MS community,” said Neil F.
McFarlane, CEO. “We remain focused on maximizing the opportunity
for GOCOVRI to benefit Parkinson’s disease patients, which includes
our recently filed sNDA for a label revision to include OFF
episodes. Moving forward we believe we have sufficient capital to
execute our near-term strategy and deliver long-term value for
shareholders.”
About
GOCOVRI®GOCOVRI® (amantadine) extended-release
capsules is the first and only FDA-approved medicine indicated
for the treatment of dyskinesia in patients with Parkinson’s
disease receiving levodopa-based therapy, with or without
concomitant dopaminergic medications. It is also the only medicine
clinically proven to reduce both dyskinesia and OFF. Taken once
daily at bedtime, GOCOVRI provides an initial lag and a slow rise
in amantadine concentration during the night, resulting in a high
concentration from the morning and throughout the waking day.
Additionally, in the clinical trials, the adjunctive use of GOCOVRI
did not require dose changes to dopaminergic therapies. The
most commonly observed adverse reactions with GOCOVRI were
hallucinations, dizziness, dry mouth, peripheral edema,
constipation, falls and orthostatic hypotension. For more
information about GOCOVRI, please visit www.GOCOVRI.com.
About ADS-5102Adamas evaluated
ADS-5102 in the INROADS Phase 3 clinical study for multiple
sclerosis patients with walking impairment. ADS-5102 was previously
approved by the FDA under the trade name GOCOVRI®. GOCOVRI is not
FDA-approved for the treatment of multiple sclerosis patients with
walking impairment.
About INROADSThe INROADS study
was a 12-week, three-arm, multi-center, randomized, double-blind,
placebo-controlled study with a 4-week placebo-run in designed to
evaluate the efficacy and safety of ADS-5102 for the treatment of
walking impairment in multiple sclerosis. The study enrolled 594
patients with walking impairment in the US and Canada and
randomized 560 patients in a 1:1:1 fashion to receive 274 mg
ADS-5102 (N=185), 137 mg ADS-5102 (N=187), or placebo (N=186). The
primary endpoint was the proportion of responders (at least 20%
improvement in Timed 25-Foot Walk from baseline) at Week 12.
Key secondary endpoints include the mean change
in the Timed 25-Foot Walk, the Timed Up and Go, and the 2-Minute
Walk at 12-week post-treatment at both the 274 mg and 137 mg
dose.
Baseline characteristics were similar across all
treatment arms. The mean time since diagnosis of MS was 15.9 years,
median Expanded Disability Status Scale at screening was 6.0, and
mean timed 25-foot walk at baseline was between 11.5 to 12.4
seconds. Prior dalfampridine use was reported in 52.5% of patients
and prior amantadine use was reported in 12.9% of patients.
Results from the study showed that patients
taking 274 mg ADS-5102 had a statistically significant improvement
in response rate of 21.1% compared to 11.3% taking placebo
(p=0.01). Response was defined as at least a 20% improvement in
walking speed from baseline to 12 weeks post-treatment, as measured
by the Timed 25 Foot Walk. Additionally, the response rate for
patients taking a lower dose of 137 mg ADS-5102 was 17.6% (p=0.08).
ADS-5102 did not demonstrate a significant effect on the secondary
walking measures at either dose.
The most common adverse events (occurring in
greater than 5% of any ADS-5102 treatment group) were: peripheral
edema, dry mouth, fall, constipation, UTI, and insomnia. 20.5% of
patients discontinued study drug due to adverse events in the 274
mg group, compared to 6.4% in the 137 mg group, and 3.8% in the
placebo group. The reported adverse events associated with ADS-5102
in this study were dose-dependent and consistent with the known
safety profile of amantadine.
About walking impairment in multiple
sclerosisMultiple sclerosis (MS) is a chronic neurological
autoimmune disease that is often disabling with unpredictable
symptoms. Among the MS patients in the US, nearly 270,000 have
walking impairment, which is present throughout the day. Walking
impairment in MS remains an area of high unmet need, as there is
only one approved product on the market for this indication.
About AdamasAt Adamas our
vision is clear – to deliver innovative medicines that reduce the
burden of neurological diseases on patients, caregivers and
society. We are a fully integrated company focused on growing a
portfolio of therapies to address a range of neurological diseases.
For more information, please visit www.adamaspharma.com.
Forward-looking
statementsStatements contained in this press release
regarding matters that may occur in the future, including the
expectations as to the long-term benefits of GOCOVRI, are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements are
subject to risks and uncertainties, and 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’
commercial activities relating to GOCOVRI, and the regulatory and
competitive environment and Adamas’ business in general, see
Adamas’ Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 7, 2020, 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, except as required
by law.
Contact:
Media:Sarah MathiesonVice President of Corporate
Communications510-450-3528smathieson@adamaspharma.com |
Investors:Peter VozzoManaging Director,
Westwicke443-213-0505peter.vozzo@westwicke.com |
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