Blog Coverage Acorda Reported Long-term Safety Data

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LONDON, UK / ACCESSWIRE / March 30, 2017 / Active Wall St. blog coverage looks at the headline from Acorda Therapeutics, Inc. (NASDAQ: ACOR) as the Company announced results from two ongoing, long-term safety studies of CVT-301 in people with Parkinson’s. The Company stated that the study showed no differences in pulmonary function between the group receiving CVT-301 and an observational control group. These results are consistent with previously reported data from Phase-2b and Phase-3 clinical trials. Register with us now for your free membership and blog access at:

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One of Acorda Therapeutics’ competitors within the Biotechnology space, Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), reported on March 09, 2017, its financial results for the year ended December 31, 2016. AWS will be initiating a research report on Corbus Pharma in the coming days.

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What is CVT-301?

CVT-301 is being developed as a self-administered, inhaled levodopa (L-dopa) therapy for the treatment of symptoms of OFF periods in people with Parkinson’s disease taking an oral carbidopa/levodopa regimen.

CVT-301 utilizes Acorda’s investigational ARCUS® platform for inhaled therapeutics. CVT-301 delivers a precise dose of a dry powder formulation of L-dopa to the lung. Oral medication can be associated with variable onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments enter the body through the lungs and reach the brain shortly thereafter, bypassing the digestive system. OFF periods are characterized by the re-emergence of Parkinson’s symptoms.

“We are delighted with these results, and plan to move forward with our NDA filing for CVT-301. These two studies, which include approximately 700 participants, represent the largest safety database evaluating long-term pulmonary function in people with Parkinson’s,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda, “We thank the study volunteers and clinical investigators, whose willingness to participate in these trials have been essential to the progress of this program.”

The Company is conducting two separate long-term safety studies:

CVT-301-005 is a 12-month, randomized, open-label study in which 271 participants with Parkinson’s who did not have a history of asthma or other chronic lung disease receive CVT-301 84 mg up to five times daily, along with usual Parkinson’s standard of care. Safety findings for participants treated with CVT-301 are compared to an observational control group of 127 participants managed with usual Parkinson’s standard of care. At the time of this analysis, all ongoing participants completed their 36 week visit and 199 participants completed their 52-week visit. Data at week-52 in study 005 showed no statistical difference in lung function compared to control.

In the CVT-301-004E study participants received one of two doses of CVT-301. There is no control arm in the study. At the time of this analysis, 70 participants completed their 36-week visit and 49 participants completed their 52-week visit. There was no control arm in study 004E. 49 participants completed their week 52 visit with no safety signals observed

Acorda announced that data from both studies will be presented at a future medical meeting. Acorda plans to file a New Drug Application (NDA) in the United States by the end of Q2 FY17 and, pending additional data analyses, plans to file a Marketing Authorization Application (MAA) in Europe by the end of 2017.

Stock Performance

At the close of trading session on Wednesday, March 29, 2017, following the announcement, Acorda Therapeutics’ share price finished yesterday’s trading session at $26.95, rising 3.26%. A total volume of 1.26 million shares exchanged hands, which was higher than the 3 months average volume of 847.98 thousand shares. The stock has rallied 46.87% and 22.17% in the last three months and past six months, respectively. Furthermore, since the start of the year, shares of the Company have surged 43.35%. At Wednesday’s closing price, the stock’s net capitalization stands at $1.25 billion.

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