Adamas Announces First Patient Enrolled in Phase 3 Trial of ADS-5102 in Multiple Sclerosis Patients with Walking Impairment
“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
“Approximately half of MS patients become dependent on some form of walking aid after 15 years due to their underlying disease,” said
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
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
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
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
For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.
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
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Source: Adamas Pharmaceuticals, Inc.