Acorda Therapeutics announces Phase 3 Fampridine-SR trial findings

Sep 10 2009

Data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis (MS) met the criteria as Extension Timed Walk Responders (ETWRs) after one year of treatment and demonstrated improved walking speed over a two year period. In addition, the safety profile of Fampridine-SR observed over two years in this study was consistent with previous placebo-controlled trials. The data were presented today at the 25^th Congress of the European Committee for Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

“Long-term data for Fampridine-SR are important because this medicine is potentially a chronic therapy for people with multiple sclerosis,” said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester, who presented the data. “The data suggest that Fampridine-SR can produce a sustained, clinically meaningful improvement in walking speed for a subset of people with MS over a two year period.”

Trial Design

In the 14-week placebo-controlled portion of the MS-F203 study, 34.8% of subjects were defined as Timed Walk Responders in the Fampridine-SR group compared to 8.3% of subjects in the Placebo group. Following the placebo-controlled study, 269 of the 283 participants who completed the study, including those defined as Timed Walk Responders, Non-Responders and participants from the Placebo group, enrolled in the open-label extension study. All participants in the extension study were treated with Fampridine-SR at 10 mg twice daily, and assessed in the clinic at 2, 14, 26, 52, 78 and 104 weeks.

Timed walk response in the extension study was defined as walking faster in the majority of the first four open-label visits (2, 14, 26 and 52 weeks) compared to the fastest off-treatment speed, which was measured at seven separate time points during the placebo-controlled trial and at screening for the extension study. Walking speed was measured using the Timed 25-Foot Walk (T25FW).

As of the cut-off date for this analysis (November 30, 2008), participants had been treated with Fampridine-SR for up to 3 years, with an average exposure of 2.1 years and a total exposure of 565 patient-years. More than half of the study participants were diagnosed with secondary-progressive MS (52.8%), with the remainder of diagnosed with relapsing-remitting MS (28.6%), primary-progressive MS (14.9%) or progressive relapsing MS (3.7%).

www.acorda.com