Acorda was up 10% early yesterday on the posting of late-stage data for certain Parkinson’s patients, but then fell during the day.
Having released top-line data back in February, a detailed look at the late-stage results showed that its experimental med, CVT-301, showed a “statistically significant and clinically meaningful improvement” in motor function, as measured by the Unified Parkinson’s Disease Rating Scale—Part III, in people with Parkinson’s experiencing OFF periods.
A number of secondary endpoints, including achievement of an ON state with maintenance through 60 minutes and Patient Global Impression of Change, were “supportive of the primary endpoint result,” the company said, although one secondary endpoint did not hit statistical significance
The 12-week, placebo-controlled trial of 339 participants saw CVT-301 84mg showing statistically significant improvement in motor function compared to placebo as measured by mean change in the UPDRS III at 30-minutes post-dose at week 12 (p=0.009).
These data were posted at the International Congress of Parkinson’s Disease and Movement Disorders (MDS), being held in Vancouver.
Acorda is developing CVT-301 as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa/levodopa regimen. So-called OFF periods mean that Parkinson’s symptoms have returned.
Leerink analysts said: “We believe the full result […] supports our fairly high, 90% odds of FDA approval. Within the full data we are encouraged with what looks to be an acceptable safety profile as well as a low, placebo-like dropout rate.
“Secondary endpoints also mostly trend or are clearly in favor of drug, including the patient global impression of change, though the lack of difference (p-value of 0.98) on total OFF time may emerge as a subject of discussion as investors debate the size of the commercial opportunity. We model ~$278MM in CVT-301 sales in 2022E, and we expect the product to be approved in the middle of next year.”
This will be a much-needed plus for Acorda which last year pulled the plug on studies for its poststroke walking difficulties med dalfampridine after it was found not to work, and said it would shifting its attention to CVT-301.
Things got worse in April when a U.S. court invalidated a number of patents for Ampyra (dalfampridine) in multiple sclerosis, leading the company to cut around 20% of its staffers to help save costs. This means that it’s become all or nothing for CVT-301.
The biotech saw its shares jump as high as $17 a share this week, but this morning was trading at $15.35 a share, with a market cap just under $800 million.