February 9, 2017
By Alex Keown, BioSpace.com Breaking News Staff
ARDSLEY, N.Y. – Shares of Acorda Therapeutics are up more than 14 percent this morning after the company announced its Phase III drug CVT-301 hit its endpoints in treating patients with Parkinson’s disease experiencing OFF periods.
Acorda data showed patients taking CVT-301 showed a statistically significant improvement in motor function. CVT-301 is an inhaled formula of levodopa (L-dopa). The inhaled formula is designed to reach the brain faster by bypassing the digestive system.
The Phase III trial compared patients on a 12-week regimen of CVT-301 versus placebo in 339 patients. Participants self-administered treatment up to five times daily for 12 weeks, the company said. Patients received a high or low dose of CVT-301 or placebo. Patients with the high dose showed a 9.83 score on the Unified Parkinson’s Disease Rating Scale-Part 3 versus a 3.91 score for placebo.
Burkhard Blank, Acorda’s chief medical officer, said in a statement that the Phase III data validated an earlier Phase IIb trial. However, Endpoints’ John Carroll reported that the Phase III data was “a significant drop” from Phase IIb results. However, Carroll noted the Phase III data was “good enough” to meet the endpoints of the Phase III trial.
Acorda said it anticipates filing a New Drug Application for approval of CVT-301 with the U.S. Food and Drug Administration in the second quarter of 2017. The company also plans to seek marketing authorization in Europe by the end of the year. The company said it will file for approval after collecting long-term safety data, which is expected later this quarter.
Parkinson’s disease is a progressive disorder of the nervous system that impacts movement in the body. In addition to the more common tremors associated with the disease, Parkinson’s commonly causes stiffness or slowing of movement, according to the Mayo Clinic. People diagnosed with Parkinson’s often deal with times classified as “ON” and “OFF.” OFF periods are characterized by the reemergence of Parkinson’s symptoms. In OFF times, which CVT-301 addresses, patients experience periods of decreased mobility. Over the course of the disease, OFF periods in patients can increase in frequency and severity. The “ON” time refers to when patients are responding to medication and symptoms are decreased.
“The re-emergence of Parkinson’s disease symptoms has a major negative impact on the lives of people with this disease, as well as on their families and care partners. Managing symptoms of OFF periods continues to be a significant unmet need for people taking oral carbidopa/levodopa regimens. Delivering levodopa by the pulmonary route offers an important treatment option for people with Parkinson’s disease,” Peter LeWitt, director of the PD and Movement Disorders Program at Henry Ford Hospital and lead investigator of the study, said in a statement.
Acorda acquired CVT-301 in a 2014 acquisition of Civitas Therapeutics. The company anticipates CVT-301 could generate $500 million in annual revenue.
The Phase III data is good news for Acorda. In September, the company announced plans to discontinue development of dalfampridine for the treatment of post-stroke walking difficulties (PSWD) following the release of Phase II data. That news came about six months after the company was forced to terminate an terminate an epilepsy drug program after its Plumiaz (diazepam) Nasal Spray failed to meet endpoints in a trial.
