EMERYVILLE, Calif., Jan. 03, 2017 (GLOBE NEWSWIRE) -- 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 Program
The 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 Platform
Adamas 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