Adamas Pharmaceuticals Completes Phase 1 Clinical Trial of ADS-4101 for Treatment of Partial Onset Seizures in Patients with ...
January 03 2017 - 4:53PM
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the
completion of a Phase 1 clinical trial of ADS-4101, an
investigational drug in development for the treatment of partial
onset seizures in patients with epilepsy. Derived from the
Company’s development platform, ADS-4101 is chrono-synchronous
lacosamide, an anti-epilepsy active ingredient previously
approved by the U.S. Food and Drug Administration (FDA) and
currently marketed as VIMPAT® (lacosamide).
There is an important need for new, clinically
differentiated treatment options for epilepsy, a chronic neurologic
disorder characterized by recurrent unprovoked seizures. Epilepsy
affects an estimated 2.2 million Americansi. Nearly two-thirds of
epilepsy patients suffer from partial onset seizures, which affect
one side of the brain. Despite advances, nearly one-third of
epilepsy patients continue to suffer from seizures. ADS-4101
is designed as a once-daily, new high strength lacosamide to
provide a clinically meaningful and differentiated treatment option
for epilepsy patients with partial onset seizures.
“We are encouraged by the results of this Phase
1 clinical trial in ADS-4101 and look forward to advancing the
program in 2017,” said Gregory T. Went, Ph.D., Chairman and Chief
Executive Officer of Adamas Pharmaceuticals, Inc. "With our
confirmed understanding that epileptic seizures primarily occur
during the day, we are developing ADS-4101 to deliver high
concentrations of medicine during the day when seizures occur. We
believe ADS-4101’s promising profile may potentially provide a
clinically meaningful benefit to patients with epilepsy.”
About the ADS-4101 Clinical Development
ProgramThe Phase 1 study of ADS-4101 was conducted in 24
healthy volunteers. The primary study objectives were to understand
the pharmacokinetics and safety of a series of chrono-synchronous
lacosamide capsule formulations and guide the selection of an
ADS-4101 formulation for further clinical development. The trial
compared the pharmacokinetic profile, safety, and tolerability of
single-doses of four oral formulations of ADS-4101 with VIMPAT
(lacosamide) tablets.
The timing of the ADS-4101 clinical development
program and its potential approval is planned to allow Adamas to
take advantage of ADS-4101’s intellectual property protections
and market opportunity.
About Adamas’ Chrono-Synchronous Therapy
PlatformAdamas has pioneered a development platform of
chrono-synchronous therapies for chronic neurologic disorders
focused on the synergy between time-dependent biologic processes
responsible for disease activity and drug response. The Company is
translating this understanding into a portfolio of products
that potentially provide clinically meaningful benefits to
patients with neurologic disorders by enabling higher doses with
manageable tolerability.
About Adamas Pharmaceuticals,
Inc.Adamas Pharmaceuticals develops new medicines to
improve the daily lives of those affected by chronic neurologic
disorders, including Alzheimer's disease, Parkinson's disease (PD),
multiple sclerosis (MS) and epilepsy. Adamas has pioneered a
platform to develop medicines, called chrono-synchronous therapies,
for chronic neurologic disorders based on an understanding of
time-dependent biologic effects of disease activity and drug
response to potentially achieve symptomatic relief without
additional tolerability issues. Its proprietary lead product
candidate, ADS-5102, is in development for levodopa-induced
dyskinesia in patients with PD and exploring other indications for
further development. Adamas is also investigating ADS-4101 for the
treatment of partial onset seizures in patients with epilepsy.
Additionally, through its license agreement with Allergan, it is
eligible to receive royalties on sales of NAMENDA XR® and NAMZARIC®
beginning in June 2018 and May 2020, respectively. For more
information, please visit www.adamaspharma.com.
NAMENDA XR® and NAMZARIC® are trademarks of Merz
Pharma GmbH & Co. KGaA. VIMPAT® is a trademark of
UCB.
Forward-looking Statements
Statements contained in this press release regarding matters that
are not historical facts 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 future profile, clinical
development, approval and success of ADS-4101 as a clinically
differentiated treatment of partial onset seizures in epilepsy.
Words such as "look forward," "on track," "expect," "potential,"
and similar expressions (as well as other words or expressions
referencing future events, conditions, or circumstances) are
intended to identify forward-looking statements. 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 our research, clinical and development activities relating to
ADS-5102 and ADS-4101, the regulatory and competitive environment
and our business in general, see our Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on November 3,
2016. Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. We undertake no obligation to update any forward-looking
statement in this press release.
i Epilepsy Foundation of America 2016;
Datamonitor Epidemiology Report 2013 American Association of
Neurological Surgeons 2016
Contact:
Martin Forrest
Vice President, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
Phone: 510-450-3528
Email: ir@adamaspharma.com
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