One of Acorda Therapeutics’ competitors within the Biotechnology space, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), reported its financial results for Q4 and full year 2016 on February 09, 2017. AWS will be initiating a research report on Regeneron Pharma in the coming days.
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“We are greatly encouraged by the efficacy and safety results of this trial, which validate the positive Phase-2b results,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda, “we would like to express our gratitude to the study volunteers and clinical investigators who participated in this trial to advance our understanding of this potentially important therapy for people with Parkinson’s.”
Acorda’s 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. OFF periods refer to the re-emergence of Parkinson’s symptoms.
According to the press release, the Phase-3 randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of CVT-301 compared to placebo in people with Parkinson’s who experience motor fluctuations (OFF periods). A total of 339 study participants were randomized and received at least one dose of CVT-301 or placebo. All participants were on a stable regimen of oral carbidopa/levodopa, and were also maintained on their other existing Parkinson’s therapies.
The primary endpoint of the study was the change at Week 12 in Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment for the 84 mg dose. Key secondary endpoints, measured at Week 12, included proportion of participants achieving an ON state within 60 minutes of treatment and maintained at 60 minutes, change in UPDRS III score at 10 and 20 minutes following treatment.
The safety profile of CVT-301 was consistent with that observed in the Phase-2b trial. Spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) tests showed no notable pulmonary safety signals. The Company is currently conducting two studies to assess the long-term safety profile of CVT-301. Up to 12-month data from these studies are expected by the end of Q1 2017.
The Company stated that 11 participants reporting serious adverse events during the trail, including three in the placebo arm of the trial, 6 in the 60 mg arm, and 2 in the 84 mg arm. There was one death in the study, judged by the investigator to not be related to studied drug. When cough was reported, it was typically mild and reported once per participant during the course of treatment. Acorda stated that 3 of 227 participants receiving CVT-301 discontinued the study due to cough.
The Company plans to file a New Drug Application (NDA) in the United States by the end of Q2 2017, pending results of the long-term safety studies. The Company also plans to file a Marketing Authorization Application (MAA) in Europe by the end of 2017, pending additional data analysis.
About Parkinson’s Disease and OFF Periods
Acorda stated that approximately one million people in the US and 1.2 million Europeans are diagnosed with Parkinson’s disease. OFF periods are experienced by approximately 350,000 in the US and 420,000 in Europe.
At the close of trading session on Thursday, February 09, 2017, following the announcement, Acorda Therapeutics’ stock price surged 20.83% to end the day at $24.65. A total volume of 5.27 million shares were exchanged during the session, which was above the 3-month average volume of 596.12 thousand shares. The Company’s share price has gained 36.94% in the past three months and 31.12% on YTD basis. The stock currently has a market cap of $1.12 billion.