EMERYVILLE, Calif., June 11, 2015 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) announced today the initiation of a Phase 2 clinical trial with ADS-5102 (amantadine HCl) in individuals with multiple sclerosis (MS) who have walking impairment.
"We are pleased to initiate this Phase 2 trial in MS patients with walking impairment to further our understanding of the safety and tolerability of ADS-5102 and to obtain data to guide our development efforts," said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc. "As our Phase 3 trials of ADS-5102 in levodopa-induced dyskinesia continue to move forward, we are identifying additional indications that will allow us to leverage our wholly-owned, extended-release formulation of amantadine and bring new treatment options to individuals in need."
Phase 2 Trial Design
This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, two arm, parallel group study of ADS-5102 in 60 individuals with MS who have walking impairment. All participants will be on a stable regimen of MS medications for at least 30 days prior to screening and will continue the same dose and regimen for the duration of their study participation. The primary study objective is to evaluate the safety and tolerability of ADS-5102 dosed at 340 mg once daily at bedtime in an MS population. Efficacy measurements will include assessments of walking and fatigue. The treatment duration will be four weeks with top-line results anticipated in 2016.
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.
Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), a high dose, extended-release version of amantadine that is administered once daily at bedtime. Adamas is initially developing ADS-5102 for the treatment of levodopa-induced dyskinesia, or LID, in patients with Parkinson's disease. LID is a complication that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for Parkinson's disease. There are no approved drugs for the treatment of LID in the United States or Europe. Adamas is also exploring the utility of ADS-5102 for the treatment of major symptoms associated with multiple sclerosis in patients with gait impairment.
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 achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication associated with the treatment of Parkinson's disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential applications, including for the treatment of symptoms associated with multiple sclerosis in patients with gait impairment. The company's portfolio also includes two approved products developed with Forest, Namzaric™ and Namenda XR®. 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.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
Namzaric™ and its design are trademarks 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 contained in this press release include expectations regarding the potential for ADS-5102 in multiple sclerosis, levodopa-induced dyskinesia and other product indications, and the 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," "will," "expect," "anticipate," "estimate," "intend," "poised," 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 relating to research and development activities of current and future products, challenges associated with clinical trials including delays in enrollment, as well as risks relating to Adamas' business in general, see Adamas' Annual Report on Form 10-Q filed with the Securities and Exchange Commission on May 13, 2015. 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.
CONTACT: For questions, please contact: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528
Source:Adamas Pharmaceuticals, Inc.