EMERYVILLE, Calif., July 9, 2015 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the completion of recruitment of its Phase 3 EASE LID study. EASE LID is a confirmatory 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.
"This important achievement brings us one step closer to our goal of filing a New Drug Application in 2016 for ADS-5102 for the treatment of LID," said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. "With recruitment of this Phase 3 study now complete, we are on track to announce top-line results in the first quarter of 2016."
EASE LID, which is enrolling approximately 120 individuals, is a 26-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 is a reduction in dyskinesia assessed by change from baseline to week 12 in UDysRS (a tool that assesses the disability and impairment of LID in Parkinson's disease) with a key secondary endpoint being change in ON time without troublesome dyskinesia as measured by patient diaries. Safety and tolerability are also being assessed.
Comprehensive Registration Program
In addition to EASE LID, Adamas has two ongoing Phase 3 clinical trials of ADS-5102 for the treatment of LID in individuals with Parkinson's disease. These clinical trials were initiated following the completion of a Phase 2/3 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). In addition, ADS-5102 increased ON time without troublesome dyskinesia by 3.8 hours, with 2.7 hours coming from a reduction in ON time with troublesome dyskinesia. 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 3, which is estimated to enroll approximately 70 patients. The 13-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 3 is a reduction in dyskinesia assessed by changes in UDysRS with a key secondary endpoint being change in ON time without troublesome dyskinesia as measured by patient diaries.
- EASE LID 2, an open-label safety study, which is also open to patients from EASED, EASE LID and EASE LID 3.
Parkinson's Disease and Levodopa-induced Dyskinesia (LID)
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 LID, 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 worsen in frequency and severity. Eventually the total time that a patient spends ON with LID can become a majority of his or her day.
About ADS-5102
Adamas' most advanced wholly owned product candidate is ADS-5102 (amantadine HCl), an extended-release version of amantadine that is administered once daily at bedtime. ADS-5102 is designed to achieve higher plasma concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening. 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 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 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 two approved products with Forest Laboratories Holdings Limited (a subsidiary of Allergan plc), 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™ is a 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 include expectations regarding the potential for ADS-5102 in levodopa-induced dyskinesia and other indications, the progress associated with our clinical trials and the potential timing of results from our EASE LID study and the filing of our New Drug Application. 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 enrollment and 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' Quarterly 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
http://health.einnews.com/article/275117061/Ja5Az66BFiAO9myj
No comments:
Post a Comment