First patient enrolled in Ph 3 Trial of ADS-5102 in MS Patients with Walking Impairment

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 570 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 570 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.

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News Source: http://ir.adamaspharma.com/releasedetail.cfm?ReleaseID=1062663

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