Acorda Therapeutics (NASDAQ: ACOR) put itself on the map three years ago when the FDA approved dalfampridine (Ampyra) to improve walking in patients with multiple sclerosis. Now, the Hawthorne, NY-based biotech is at it again, hoping that some promising data can open up a new revenue stream for its sole drug on the market.
Acorda released the results today of a mid-stage clinical trial testing dalfampridine in 83 patients who had experienced an ischemic stroke—in which a cardiovascular clot or plaque breaks free in the blood vessels and blocks the flow of blood and oxygen to the brain—at least six months earlier. The trial was a double-blind crossover study—meaning that one group of patients received Acorda’s drug for a short period of time, then switched to a placebo, and a second group did so in reverse order.
Acorda measured the drug’s effectiveness with a timed 25-foot walk test. The new drug helped patients walk better than a placebo, and the results were statistically significant, meaning they are unlikely a result of chance, Acorda said. Patients on the new drug also showed an improvement in tasks of independent daily living, like bathing, grooming, and eating, the company said. Acorda didn’t provide specifics, however, on how much improvement its drug offered, only saying that the study showed enough promise to keep the program moving.
“There were promising efficacy signals in the post-stroke trials,” Acorda CEO Ron Cohen told analysts on a conference call today. “The fact that we see this is very encouraging.”
Cohen (an Xconomist) added that Acorda will now finish analyzing all of the data from the study and discuss a further development program with the FDA.
Acorda said the drug was well-tolerated, and the most common side effects included dizziness, fatigue and insomnia. Though three people experienced seizures during the trial, one patient was part of the placebo group, while a second intentionally overdosed in what was judged to be a suicide attempt.
Further success in the clinic could ultimately help significantly expand Acorda’s most important franchise. There are no approved drugs that improve walking ability and manual dexterity for patients recovering from stroke. About 7 million people in the U.S. are living with the long-term effects of stroke, and about half of them, some 3.5 million, have ongoing sensory motor deficits and walking difficulties, Cohen told analysts.
Investors cheered the news, sending shares up more than 9 percent to $34.43 at 12:43 pm Eastern time. Acorda hasn’t closed near $35 per share since late 2010.
Acorda began selling dalfampridine in March 2010 and it has turned the company from a money-losing R&D organization into a profitable, fully-integrated company. After pulling in $210.5 million in sales in 2011, dalfampridine ramped up to $266.1 million in 2012, enabling Acorda to report $25.6 million in operating income.
Acorda is also testing the drug in cerebral palsy, though it hasn’t determined whether it will move forward with the program as of yet.
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