Acorda says current phase 3 trial could serve as primary proof of efficacy for Fampridine-SR

By Jennifer Lanning Drey

Eugene, Ore., July 13 - Acorda Therapeutics' current phase 3 clinical trial of its lead product Fampridine-SR for multiple sclerosis could serve as the primary trial proving efficacy, said Ron Cohen, chief executive officer of Acorda, on Thursday during a company investor conference.

However, on Wednesday the company announced it had pushed back the timing of when it expects to have results from the trial to late September or October. Results were previously expected in the third quarter. Acorda said it would not be discussing the delay during the investor conference.

The primary endpoint of the phase 3 trial of Fampridine-SR is improvement in walking ability.

"By far, the number one concern of these patients is the loss of mobility, the loss of strength and its concomitant loss of independent function. Right now, there is nothing that addresses that for these patients, and we believe that Fampridine-SR is the first drug ever to show ability to do that," Cohen said.

The phase 3 clinical trial is modeled after Acorda's MS-F202 phase 2 clinical trial for the drug, which found that patients demonstrated, on average, a 27% improvement in walking speed while taking the drug, Cohen said.

The Food and Drug Administration has told Acorda that for the phase 3 trial to serve as the primary efficacy trial, it must also specifically show that responders had a greater response on the MS Walking Scale than the non-responders.

In addition, the FDA said the study must also show that the Fampridine-SR responders showed greater improvement at their last visit.

"What we need to do is show that at the end, it's consistent; that at the end, you're still seeing separation between the drug group and placebo, as we did in the 202 study," Cohen said.

The company has randomized the 301 patients in the phase 3 trial at a 3-to-1 drug to placebo ratio and has selected 10 mg as the optimal dose for the study, he said.

Like in the MS-F202 study, baseline will be the patient's fastest walking time clinically measured before taking the drug. Acorda will compare that time to four others demonstrated by the patient while taking the drug.

"That is a consistent walking improvement," said Cohen.

The phase 2 clinical trials began by looking at average improvements in walking times; however, because multiple sclerosis is an inherently inconsistent condition, the company switched to comparing patients before and during drug treatment on an individual basis.

"The issue for us was, if you're trying to show benefit based on averaging an entire group, within those averages, you have this enormous individual variability and that cuts your statistical power," said Cohen.

In the phase 3 clinical trial, the company will look at each patient visit and walking time individually, he said.

If approved, Acorda plans to market Fampridine-SR to neurologists.

Based in Hawthorne, N.Y., Acorda is a biotechnology company developing therapies to restore neurological function in people with spinal cord injury, multiple sclerosis and related conditions of the nervous system.

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