EMERYVILLE, Calif., Dec. 14, 2015 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the completion of enrollment in its Phase 3 EASE LID 3 study. EASE LID 3 is a clinical trial designed to evaluate the efficacy and safety of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID), a motor complication associated with the treatment of Parkinson’s disease.
“We are pleased to have completed enrollment of EASE LID 3, our third randomized clinical study in this indication, and we expect to maintain momentum in advancing our ADS-5102 program for the treatment of LID,” said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We look forward to announcing top-line data from the EASE LID and EASE LID 3 trials in the near future and being one step closer to a potential new treatment option for Parkinson’s patients experiencing the often debilitating effects of levodopa-induced dyskinesia.”
EASE LID 3, which enrolled 77 patients, is a 13-week multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime. The primary endpoint of EASE LID 3 is a reduction in dyskinesia assessed by changes in Unified Dyskinesia Rating Scale (UDysRS) from baseline to week 12.
Comprehensive Phase 3 Program
Adamas has three ongoing clinical trials of ADS-5102 for the treatment of LID in individuals with Parkinson’s disease. These clinical trials, which were initiated following the completion of a Phase 2/3 study, include two Phase 3 trials and one open-label safety study.
Completed Phase 2/3 Trial
- EASED, a randomized, placebo-controlled, multi-center study, evaluated patients with Parkinson’s disease experiencing troublesome LID. Patients were randomized to receive placebo or to one of three dose levels of ADS-5102. As previously reported, ADS-5102 at 340 mg/day significantly reduced LID as measured by change in UDysRS over eight weeks versus placebo (primary endpoint, p=0.005). Data also suggested that ADS-5102 was generally well tolerated and reported adverse events were consistent with Parkinson’s disease and the known amantadine safety profile.
Ongoing Phase 3 Studies
- EASE LID, a confirmatory Phase 3 study, enrolled approximately 120 patients. The 26-week multi-center, randomized, double-blind, placebo-controlled study will assess the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime. The primary endpoint of EASE LID is a reduction in dyskinesia assessed by changes in UDysRS at week 12.
- EASE LID 3, a confirmatory Phase 3 study, as described above.
- EASE LID 2, an open-label safety study, which is open to patients from EASED, EASE LID and EASE LID 3, as well as LID patients who have undergone deep brain stimulation.
Parkinson’s Disease and Levodopa-induced Dyskinesia
Parkinson's disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability. The most commonly prescribed treatments for Parkinson’s disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. Patients initially receive relief from symptoms of Parkinson’s disease for much of the day. This period of relief is known as ON time. As the effects of levodopa wear off, the symptoms of Parkinson’s disease return. This is known as OFF time.
As Parkinson’s disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Patients may also experience symptoms of their disease upon waking, prior to the first dose of levodopa taking effect. Over time many patients will suffer from levodopa-induced dyskinesia, a condition characterized by involuntary movements without purpose. LID can become severely disabling, rendering patients unable to perform routine daily tasks. As Parkinson’s disease advances, the symptoms of LID often worsen in frequency and severity. Eventually the total time that a patient spends ON with LID can become a significant portion of his or her day.
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 for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease and 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 driven to improve the lives of those affected by chronic disorders of the central nervous system. Adamas is currently developing ADS-5102, its lead wholly-owned product candidate, for the treatment of levodopa-induced dyskinesia 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 contained in this press release such as expectations regarding the potential for ADS-5102 in levodopa-induced dyskinesia, the progress associated with our clinical trials and the potential results from our EASE LID and EASE LID 3 studies. 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,” 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, clinical and development activities of ADS-5102, challenges associated with clinical trials including delays in completion of our studies, and failure to demonstrate safety and efficacy of ADS-5102, 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 November 12, 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.
For questions, please contact: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528
Source:Adamas Pharmaceuticals, Inc.