Acorda Therapeutics announced initial results of both a Phase 2 clinical trial of its lead product candidate, Fampridine-SR, in people with multiple sclerosis (MS), and two Phase 3 trials in people with chronic spinal cord injury (SCI).
Data from the MS trial showed a strong positive trend in improvement of walking speed and a significant improvement in leg muscle strength, the trial’s primary and secondary endpoints. Data from one of the two SCI trials showed a strong positive trend in a primary endpoint of reducing muscle spasticity, but neither SCI trial achieved statistical significance in its primary endpoints.
Acorda plans to meet with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 trial of Fampridine-SR in MS and further development for SCI.
"The MS study data further confirm results from two previous Phase 2 trials of Fampridine-SR’s potential to benefit people with MS. We are excited by this result and are looking forward to discussing next steps with the FDA. While we are disappointed in the overall outcome of the SCI trials, they did provide further evidence of potential benefit in this indication, consistent with data from our previous studies. Acorda will continue to investigate the use of Fampridine-SR for spinal cord injury," said Ron Cohen, M.D., Acorda's president and chief executive officer.
The MS trial showed a strong positive trend compared to placebo in its primary endpoint, improvement in walking speed, as measured by a timed 25-foot walk. The trial also showed a statistically significant improvement across dose groups in its secondary endpoint, the Lower Extremity Manual Muscle Test (LEMMT). These data are consistent with data from earlier double-blind trials that involved fewer subjects and shorter treatment periods. Because most people with MS experience both impairment in walking ability and weakened muscles, the Timed 25 Foot Walk is widely used to assess MS patients’ functional status. The LEMMT is a standardized, 5-point manual assessment of strength, applied to leg muscle groups. Analysis of the other secondary endpoints in the trial is ongoing.
Andrew Goodman, M.D., director of the MS Center at the University of Rochester Medical School and chair of the company’s MS advisory group, said, “We are encouraged by the findings of this Phase 2 trial of Fampridine-SR in MS because impaired walking and muscle weakness are two of the most common and devastating aspects of this disease. There is a tremendous unmet need for treatments that can improve walking and weakness, as none of the currently available therapies can do so.”