EMERYVILLE, Calif., Feb. 17, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) will present results from its Phase 2 proof-of-concept study of ADS-5102 (amantadine hydrochloride) extended-release capsules for the treatment of walking impairment in patients with multiple sclerosis (MS) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2017. In the study, patients on ADS-5102 showed an approximate 17 percent placebo-adjusted improvement in walking speed in the Timed 25 Foot Walk (T25FW) test (p<0.05) and an approximate three second placebo-adjusted improvement in the Timed Up and Go (TUG) test (p<0.10). In addition, ADS-5102 was generally well tolerated.
“This Phase 2 proof-of-concept study of ADS-5102 has generated encouraging data across several performance measures in multiple sclerosis patients,” said Rajiv Patni, M.D., chief medical officer of Adamas. “If these data are confirmed in longer duration, controlled clinical trials, ADS-5102 may offer an additional treatment option for multiple sclerosis patients experiencing impairments in walking ability, which are issues that a large number of patients with multiple sclerosis confront.”
Phase 2 Proof-of-Concept Study Design and Results
The multi-center, randomized, double-blind, placebo-controlled Phase 2 study was designed to evaluate ADS-5102 in MS patients with walking impairment for four weeks. The study enrolled 60 MS patients who had impaired walking speed at baseline. The primary study objective was to evaluate the safety and tolerability of 340 mg ADS-5102 dosed once daily at bedtime. Exploratory efficacy analyses included the change from baseline to week four in the T25FW, the TUG, the 2 Minute Walk Test (2MWT) and the Multiple Sclerosis Walking Scale-12 (MSWS-12). Other outcome measures included assessments of fatigue, cognition and depression. Background MS medications were not changed during the course of the study.
Efficacy results were obtained from a modified intent-to-treat population that included 56 subjects who received at least one dose of ADS-5102 and provided at least one post-baseline walking assessment. An analysis using the mean changes from baseline to week four efficacy measures showed an approximate 17 percent placebo-adjusted improvement in walking speed in the T25FW test (p<0.05) and an approximate three second placebo-adjusted improvement in TUG (p<0.10). No effects were noted for fatigue, cognitive dysfunction or depression.
ADS-5102 was generally well tolerated in this study population. One serious adverse event was reported in the study, suspected serotonin syndrome, reported as drug related by an investigator. The most frequent adverse events (AEs) reported in the ADS-5102 treatment group were dry mouth, constipation and insomnia. Five ADS-5102 patients and no placebo patients discontinued treatment due to AEs.
Details on Presentation at ACTRIMS
Dr. Jeffrey Cohen, professor of neurology and director of the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research, will present the findings from this study during a poster session at the ACTRIMS Forum in Orlando, Fla.
| Poster Title: | A Phase 2 Study of ADS-5102 (amantadine hydrochloride) Extended Release Capsules in Multiple Sclerosis Patients with Walking Impairment |
| Poster Number: | P207 |
| Date: | Thursday, February 23, 2017 |
| Time: | 7:00 – 9:00 p.m. |
About ADS-5102
ADS-5102 is a chrono-synchronous amantadine therapy with potential applications across a number of chronic neurologic disorders. Adamas is focusing initial development on the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. A New Drug Application (NDA) supporting ADS-5102 for the treatment of LID in patients with Parkinson’s disease is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017. The Company is also investigating ADS-5102 for the treatment of walking impairment in multiple sclerosis patients and is considering developing it for other indications in Parkinson’s disease earlier in the treatment journey.
About Multiple Sclerosis and Walking Impairmenti
Multiple sclerosis is a chronic autoimmune-mediated disorder that affects more than 2 million people worldwide and 400,000 people in the United States, where there are approximately 270,000 diagnosed and treated patients. Multiple sclerosis manifests as unpredictable symptoms that can vary in severity and tend to progress over years, in some cases to near total disability. Walking impairment, which affects approximately 80 percent of diagnosed patients, is associated with an increased risk of falls and has a substantial impact on daily activities. Despite therapeutic advances, unmet medical needs remain for MS patients with walking impairment, including the need for a therapeutic agent that delivers an improvement in walking ability during the day.
About Adamas Pharmaceuticals, Inc.
Adamas is developing new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Parkinson's disease, multiple sclerosis, epilepsy and Alzheimer's disease. Adamas has pioneered a platform to develop medicines, called chrono-synchronous therapies, for chronic neurologic disorders based on an understanding of the time-dependent biologic processes responsible for disease activity and drug response to potentially achieve symptomatic relief without tolerability issues. The company’s most advanced product candidate, ADS-5102, is in development for levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease and for walking impairment in patients with multiple sclerosis. An NDA supporting ADS-5102 for the treatment of LID in patients with Parkinson’s disease is under review by the FDA, with a PDUFA date of August 24, 2017. Adamas is exploring other indications for ADS-5102 for further development. Adamas is also investigating ADS-4101 for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas’ licensed assets, NAMENDA XR® and NAMZARIC®, are currently marketed by Allergan, and Adamas is eligible to receive royalties on sales of these medicines 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.
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 approval and commercialization of ADS-5102 for treatment of levodopa-induced dyskinesia in patients with Parkinson's disease, a potential registration program for ADS-5102 for treatment of walking impairment in MS, additional indications for ADS-5102, and additional products such as ADS-4101. Words such as "will," "may," "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 Adamas Pharmaceuticals’ most recent 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. Adamas Pharmaceuticals undertakes no obligation to update any forward-looking statement in this press release.
i Noonan et al 2002; Coleman 2013; Evaluate Pharma 2016.