Acorda Therapeutics has tried for some time to expand the use of its flagship drug, dalfampridine (Ampyra). Demonstrating that it could help people walk better after suffering a stroke was perhaps its biggest opportunity. But the Ardsley, NY, company is now scrapping those plans altogether.
Acorda (NASDAQ: ACOR) said this morning it will no longer test dalfampridine (Ampyra) in stroke patients who are having trouble walking. A phase 2 study in those patients didn’t show what the firm called “sufficient efficacy” to warrant further development. About 7 million people in the U.S. are living with the long-term effects of stroke, and about half of them have ongoing sensory motor deficits and walking difficulties, according to Acorda.
Acorda’s goal in the 368-patient, 12-week trial was to show dalfampridine led to least a 20 percent improvement in the distance a patient can walk in two minutes. Scores on the two-minute walk test were taken at the start of the study and after 12 weeks of treatment. Acorda said 23 of 121 patients (19 percent) on a high dose of dalfampridine and 17 of 121 patients (14 percent) on a low dose had a 20 percent improvement, compared to 17 of 126 (13.5 percent) of placebo patients.
The most common side effects were urinary tract infections, falls, dizziness, and fatigue. Acorda said it would disclose more data from the study at a future medical meeting.
“The study indicated there was activity related to walking in people with [post-stroke walking difficulties], as suggested by the prior Phase 2 study, but overall this was not sufficiently clinically meaningful,” said CEO Ron Cohen (pictured), in a statement.
Shares of Acorda fell over 15 percent in pre-market trading on Monday.
The news puts more pressure for success on Acorda’s pipeline of experimental Parkinson’s disease drugs, which the company has accumulated from other sources over years of deal-making. Dalfampridine was approved by the FDA in 2010 to improve the walking ability of patients with multiple sclerosis, turning Acorda from a money-losing R&D organization into a profitable, fully-integrated company. The drug generated $437 million in sales in 2015, and Acorda pocketed about $11 million in net income.
Acorda has been trying to expand the use of dalfampridine and diversify its product line at the same time with some setbacks. In 2012, for instance, the company bought Neuronex for its nasal spray form of the old seizure control drug diazepam, but shelved it four years later after disappointing data. The company had hoped positive dalfampridine data in post-stroke patients would set the stage for further testing, but given the disappointing data today, those studies will never materialize.
Acorda will now turn its attention to its two experimental Parkinson’s drugs: CVT-301 and tozadenant (now known as SYN115). Acorda bought Civitas Therapeutics in 2014 for $525 million to get its hands on CVT-301, an inhalable version of the decades-old Parkinson’s drug, levodopa. And in January, Acorda bought Biotie Therapies for $363 million to get SYN115, which, like CVT-301, is meant to help Parkinson’s patients during their “off” episodes, when their medications stop working.
Acorda should have Parkinson’s results soon. A Phase 3 trial of CVT-301, a critical event for the company, is expected to wrap up early next year. SYN115 is also in Phase 3 testing.