Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a clinically
meaningful difference to people affected by neurological diseases,
today announced that INROADS, a 3-arm, randomized, double-blind,
placebo-controlled study in 594 multiple sclerosis (MS) patients
with walking impairment met its primary endpoint.
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.
“We are pleased that ADS-5102 shows a potential
benefit for MS patients with walking impairment, for whom there is
a significant unmet medical need and limited treatment options,“
said Neil F. McFarlane, Chief Executive Officer of Adamas
Pharmaceuticals, Inc. “However, as we did not see the scale of
clinical benefit we had hoped for in this study we will fully
assess the potential for ADS-5102 in MS patients before determining
the extent of our continued investment in this program.”
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.
“We would like to extend our sincere thanks to
everyone involved in this study including the patients,
investigators, and coordinators,” said Rajiv Patni, M.D., Chief
Medical Officer of Adamas Pharmaceuticals, Inc. “We will now
complete our analyses of these data to fully characterize the
efficacy and safety profile of ADS-5102 and the dose response seen
in this study. Given these data, we will not initiate the
originally planned replicate second Phase 3 placebo-controlled
study. We are continuing the open-label extension study and
will engage with the FDA to discuss a potential regulatory
pathway.”
“Walking impairment negatively impacts many
aspects of daily life for a large number of patients, and
additional treatment options are needed,” said INROADS Steering
Committee Chair, Jeffrey Cohen, M.D., Director of experimental
therapeutics at the Mellen Center for Multiple Sclerosis at
Cleveland Clinic and a paid consultant for Adamas. “This trial
result is encouraging for the MS patient and physician community
and we look forward to reviewing the full data set.”
About ADS-5102
Adamas is evaluating 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® (amantadine) extended-release capsules for the
treatment of dyskinesia in patients with Parkinson’s disease
receiving levodopa-based therapy. GOCOVRI is not FDA-approved for
the treatment of multiple sclerosis patients with walking
impairment.
About INROADS
The 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 EDSS 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.
About Walking Impairment in Multiple
Sclerosis Multiple 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 Adamas Pharmaceuticals,
Inc.
At Adamas, our purpose is clear: deliver
innovative medicines that make a clinically meaningful difference
for patients, caregivers and society. We are a fully-integrated
company with a growing portfolio of therapies that address a range
of neurological diseases. For more information, 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 Adamas’ development plans
for ADS-5102, including its plan to fully assess its program in
multiple sclerosis walking impairment and engage with the FDA on a
potential regulatory pathway. 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’ research, clinical,
development and commercial activities relating to GOCOVRI and
ADS-5102, 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 November
7, 2019, 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:
Investors: Peter Vozzo Managing Director, Westwicke 443-213-0505
peter.vozzo@westwicke.com
Media: Sarah Mathieson Vice President of Corporate
Communications 510-450-3528 smathieson@adamaspharma.com
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