EMERYVILLE, Calif., April 03, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the first patient has been enrolled in its pivotal Phase 3 clinical trial of ADS-5102 (amantadine) extended release capsules in multiple sclerosis (MS) patients with walking impairment. The three-arm, multi-center, randomized, double-blind, placebo-controlled study is expected to enroll up to 540 MS patients with walking impairment in the United States.
“Initiating this Phase 3 study of ADS-5102 in MS patients with walking impairment is a significant milestone for Adamas, as it could potentially advance the approval of GOCOVRI (amantadine) extended release capsules as a treatment for this MS population,” said Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, Inc. “The goal of the study is to confirm the results of our Phase 2 proof-of-concept study and to demonstrate the efficacy and safety of ADS-5102 using several measures of walking in MS patients. This study deepens our commitment to patients and has the potential to further validate Adamas’ unique approach to drug development using time-dependent biology.”
“Approximately half of MS patients become dependent on some form of walking aid after 15 years due to their underlying disease,” said Aaron Miller, M.D., Medical Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at the Icahn School of Medicine at Mount Sinai in New York and a member of the steering committee for the trial. “There is a significant unmet medical need for additional therapies to treat impaired mobility in MS as the current approved treatment option, for this critically important function, is demonstrated to not be effective for a majority of patients.”
The Phase 3 trial is based on the positive Phase 2 proof-of-concept data of ADS-5102 in MS patients with walking impairment. The study found a statistically significant 17 percent improvement in walking speed from baseline and that a greater proportion of ADS-5102-treated patients experienced at least a 20 percent improvement in walking speed from baseline compared to placebo-treated patients.
About the Study
The study is a three-arm, multi-center, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 in 540 patients with MS who have walking impairment in the United States. The primary objective will be to evaluate the efficacy of a once-daily 274 mg dose of ADS-5102 administered at bedtime in MS patients with walking impairment as measured by the Timed 25-foot Walk (T25FW, feet/second) at Week 12. Secondary objectives are to evaluate the efficacy of 274 mg ADS-5102 in MS patients with walking impairment as measured by the Timed Up and Go (TUG) test, and the 2-Minute Walk Test (2MWT) at Week 12; as well as to evaluate the efficacy of a 137 mg dose of ADS-5102, administered once-daily at bedtime, in MS patients with walking impairment as measured by the T25FW, the TUG test, and the 2MWT at Week 12.
See www.clinicaltrials.gov for further information (NCT03436199).
About Multiple Sclerosis and Walking Impairmenti
Multiple sclerosis (MS) is a chronic autoimmune-mediated disorder and manifests as unpredictable symptoms that can vary in severity and tend to progress over years, in some cases to near total disability. Walking, which depends on the coordinated functioning of multiple CNS motor and sensory systems, is frequently impaired in MS and affects a majority of the approximately 400,000 MS patients in the United States. Walking impairment in MS patients remains an area of high unmet need, as there is only one approved product on the market for this indication.
About ADS-5102
ADS-5102 is a high-dose amantadine taken once-daily at bedtime, which delivers consistently high levels of amantadine upon walking and throughout the day. ADS-5102 was previously approved by the U.S. Food and Drug Administration (FDA) under the trade name GOCOVRI™ (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is not FDA-approved for the treatment of walking impairment in multiple sclerosis patients.
About Adamas Pharmaceuticals, Inc.
Adamas is using its deep understanding of time-dependent biology to redefine the treatment experience for patients suffering from chronic neurological diseases. The company is building upon the commercial launch of GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease, with a pipeline of differentiated investigational programs, which includes: ADS-5102 in development for the treatment of multiple sclerosis walking impairment; and ADS-4101, a high-dose, modified release lacosamide in development for the treatment of partial onset seizures in patients with epilepsy. Adamas’ goal is to create and commercialize a new generation of neurological medicines intended to lessen the burden of disease on patients, caregivers and society.
For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.
Forward-looking Statements
Statements contained in this press release regarding matters that may occur in the future 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 clinical benefits of GOCOVRI or about Adamas’ ongoing or planned clinical development programs 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 Adamas' research, clinical, development and commercial activities relating to GOCOVRI and ADS-5102, the regulatory and competitive environment and Adamas' business in general, see Adamas’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 22, 2018, particularly under the caption “Risk Factors.” 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.
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