The near $1 billion market cap company said its “Milestone” study “did not show sufficient efficacy to support further development of dalfampridine to improve poststroke walking difficulties (PSWD).” Its shares dropped sharply premarket this morning by 13%.
So what happened? In a statement, the biotech said the measure of its success was the proportion of participants who showed at least a 20% improvement on the Two Minute Walk Test (2MinWT) at week 12 as compared to baseline.
In the Milestone test, however, the biotech’s med saw just 23 out of 121 (19%) of those receiving the higher 10-mg dose of dalfampridine twice a day, and 17 of 121 (14%) participants getting the lower 7.5-mg dose of dalfampridine, showing at least that 20% improvement on the 2MinWT. On a dummy therapy, 17 out of 126 (13.5%) achieved the same.
Those taking the drug also seem to have had more falls, as well as urinary tract infections and dizziness.
While no seizures were reported in the dalfampridine 10-mg group, two seizures were reported in the 7.5-mg group and three in the placebo group.
The drug is already approved as a treatment to help certain multiple sclerosis patients walk better under the name Ampyra (dalfampridine).
Ron Cohen, president and CEO of Acorda, said he was “disappointed by this outcome.”
He went on: “The study indicated there was activity related to walking in people with PSWD, as suggested by the prior Phase II study, but overall this was not sufficiently clinically meaningful. I want to express our gratitude to the study participants, their care partners and clinicians, who gave their time and commitment to this research.”
He said that the co would now refocus on the new pipeline it has been building up over the past three years.
This includes further work on its late-stage Parkinson’s disease therapies, CVT-301 and tozadenant, as well as advancing its earlier stage assets, CVT-427 in migraine, SYN120 in Parkinson’s disease dementia, and rHIgM22 in MS.