EMERYVILLE, Calif., Oct. 12, 2015 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced findings from two nonclinical studies that demonstrate the potential of ADS-5102 for the treatment of multiple sclerosis (MS) symptoms. One study demonstrated improvement in walking in in vivo models of MS. Data from the second study provide insights into the potential mechanisms of action of amantadine in MS. These results (Abstract P863) were presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Barcelona, Spain.
“We are encouraged by these nonclinical data and what they mean with respect to the potential of ADS-5102, our extended release version of amantadine, in addressing MS-related symptoms, including walking impairment,” stated Natalie McClure, Ph.D., Senior Vice President of Product Development at Adamas Pharmaceuticals, Inc. “With the improved pharmacokinetic profile of ADS-5102, we can potentially administer higher therapeutic doses than is common with immediate release amantadine.”
Researchers conducted nonclinical studies designed to evaluate the efficacy of amantadine for the treatment of MS-related symptoms, including walking impairment, in in vivo models of MS and to better understand the mechanisms of action of amantadine in MS. Data demonstrated that in models of MS, chronic administration of amantadine at a dose intended to match the human plasma levels of ADS-5102 improved walking. Additionally, data from an in vitro study demonstrated that amantadine blocked neuronal potassium channel activity, which may result in enhanced electrical impulses across demyelinated regions of neurons. Data from these studies suggest that ADS-5102 may have clinical utility in the treatment of major symptoms associated with MS, including walking impairment.
In June 2015, Adamas announced the initiation of a Phase 2 clinical trial of ADS-5102 for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment. The study, which will enroll approximately 60 patients, is designed to evaluate the safety and tolerability of ADS-5102 dosed at 340 mg once daily at bedtime in an MS population. Efficacy measurements include assessments of walking and fatigue. The treatment duration is four weeks with top-line results anticipated in 2016.
About MS
MS is a chronic autoimmune-mediated disorder that affects approximately 270,000 people in the United States. While there are multiple drugs approved to reduce inflammation and slow the development of symptoms early in the disease course, there are limited options available for the treatment of the frequent and often persistent neurological symptoms. In a 2013 patient survey on MS in America, 76 percent of respondents reported walking difficulties and 89 percent reported fatigue.
About ADS-5102
Adamas’ most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), an extended-release version of amantadine that is intended for once daily administration at bedtime. ADS-5102 is designed to improve upon the pharmacokinetic (PK) profile of immediate release amantadine, with the aim of enhancing efficacy without compromising the known tolerability profile. In PK studies, ADS-5102 has been shown to achieve high plasma amantadine concentrations in the early morning that are sustained throughout the afternoon and are lower in the evening, potentially providing therapeutic benefit when needed most. Adamas is currently evaluating ADS-5102 in Phase 3 clinical trials for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease and in a Phase 2 clinical trial for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment. There are currently no approved drugs in the United States or Europe for the treatment of LID.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company seeks to achieve this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing ADS-5102, its lead wholly-owned product candidate, for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease and for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment. The company’s portfolio also includes Namzaric™ and Namenda XR®, two approved products with Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan plc. Forest is responsible for marketing both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.
Namzaric™ is a trademark of Merz Pharma GmbH & Co. KGaA.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA
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 regarding the potential application and ongoing development of ADS-5102 for multiple sclerosis (MS) symptoms as well as progress and timelines associated with our clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “may,” “can,” “plan,” “will,” “expect,” “anticipate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks associated with research and development activities of ADS-5102, including challenges and delays associated with clinical studies, regulatory review and requirements, as well as risks relating to Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2015.
CONTACT: For questions, please contact: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528