Shares of Acorda Therapeutics Inc. (NASDAQ: ACOR) saw a handy gain in early trading on Thursday after the company reported results from its late-stage Parkinson’s trial. Basically, the company announced Phase 3 clinical data of CVT-301, showing a statistically significant improvement in motor function in people with Parkinson’s disease experiencing so-called off periods.
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. The UPDRS III change for the 84 mg dose in the trial was −9.83 compared to −5.91 for a placebo. UPDRS III is a validated scale, which measures Parkinson’s motor impairment.
The safety profile of CVT-301 in this study was consistent with the Phase 2b trial.
Acorda plans to file a New Drug Application (NDA) in the United States by the end of the second quarter of 2017, pending results of the long-term safety studies. It also plans to file a Marketing Authorization Application (MAA) in Europe by the end of 2017.
Some brief background: CVT-301 is an investigational, inhalable formulation of levodopa (L-dopa). It is being studied as a treatment for 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.
Burkhard Blank, M.D., chief medical officer of Acorda, commented:
We are greatly encouraged by the efficacy and safety results of this trial, which validate the positive Phase 2b results. 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.
Excluding Thursday’s move, Acorda has outperformed the broad markets, with the stock up 8.5% year to date. Over the past 52 weeks, the stock is actually down 44%.
Shares of Acorda were last seen up 12% at $22.85, with a consensus analyst price target of $32.00 and a 52-week trading range of $16.40 to $37.36.