In a phase 3 clinical trial (NCT03436199)Of those treated with a 274-mg dose of amantadine extended release, 21.1% had at least a 20% improvement in walking speed over 12 weeks as measured by the Timed 25-Foot Walk compared with 11.3% of those treated with placebo (P=.01). For those who took a lower dose (137 mg) 17.6% had at least a 20% improvement in walking speed (P=.08).
“We are pleased that ADS-5102 shows a potential benefit for MS patients with walking impairment, for whom there is a significant unmet medical need and limited treatment options,” said Neil F. McFarlane, CEO, Adamas. “However, as we did not see the scale of clinical benefit we had hoped for in this study, we will fully assess the potential for ADS-5102 in MS patients before determining the extent of our continued investment in this program.”
“We will now complete our analyses of these data to fully characterize the efficacy and safety profile of ADS-5102 and the dose response seen in this study,” said Rajiv Patni, MD, chief medical officer, Adamas. “Given these data, we will not initiate the originally planned replicate second phase 3 placebo-controlled study. We are continuing the open-label extension study and will engage with the FDA to discuss a potential regulatory pathway.”
This study enrolled 594 individuals with MS and walking impairment. The study randomized 560 participants in a 1:1:1 fashion to receive 274 mg of the therapy (n=185), 137 mg (n=187), or placebo (n=186).
Svetlana Primma Eckert, MD, Bianca Weinstock-Guttman, MD, and Stephen Krieger, MD
Adil Javed, MD, PhD, and James Stankiewicz MD, FAAN
Thomas P. Leist, MD