November 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
ARDSLEY, N.Y. – Following the release of disappointing Phase II data, shares of Acorda Therapeutics are dropping this morning after the company announced plans to discontinue development of dalfampridine for the treatment of post-stroke walking difficulties (PSWD).
Ron Cohen, president and chief executive officer of Acorda, called the drug termination disappointing. In a statement this morning, he indicated data from a previous Phase II study indicated there was “activity related to walking in people with PSWD,” but it wasn’t clinically meaningful.
In the study, patients received 7.5 or 10 mg doses of dalfampridine twice per day or a placebo. The study was hoping to show that a proportion of patients demonstrated at least a 20 percent improvement on a walking test after 12 weeks of dosing compared to a baseline. However, the study showed that 23 of 121 patients on the 10 mg dose, about 19 percent and 17 of 121 who received the 7.5 mg dose, or 14 percent, showed at least a 20 percent improvement. Placebo patients showed a 13.5 percent improvement, the company said. While the drug may have shown some effect, the company said it was not statistically significant enough to continue.
Shares of Acorda fell about 13 percent in pre-market trading and are down more than 5 percent since the market opened. Shares were trading at $20.20 as of 9:48 a.m. Investors have not been happy with Acorda over the past 12 months.
Share prices have fallen more than 50 percent since December 2015. Shares were trading at $43.25 on Dec, 29, 2015.
The news comes about six months after the company was terminate an epilepsy drug program after its Plumiaz (diazepam) Nasal Spray failed to meet endpoints in a trial.
Now that the company has eliminated two drug programs within the last six months, Acorda said it plans to focus its R&D efforts on its Parkinson’s disease program, which includes CVT-301, an inhaled form of levodopa, which is in late-stage studies. The company also has earlier stage programs for migraine treatment, another Parkinson’s disease and dementia treatment, as well as another for multiple sclerosis.
Cohen said the company maintains a diverse pipeline in order to offset risks of program failures.
In addition to terminating two drug programs, Acorda also saw a shakeup in its leadership. In October, Chief Financial Officer Michael Rogers left the company. Rogers had been commuting to company offices from Boston, which the company alluded to being part of the reason he left.
