AAN 2025 | 24-month Phase I results: safety and early efficacy of bemdaneprocel in Parkinson’s disease
Harini Sarva, MD, Weill Cornell Medicine, New York, NY, shares 24-month results from a Phase I open-label study (NCT04802733) evaluating bemdaneprocel in patients with Parkinson’s disease. The study primarily assessed safety and tolerability, which were confirmed as primary endpoints at the one-year mark. Clinical efficacy was explored through secondary endpoints, showing signs of stability or improvement in motor and non-motor symptoms. Although the sample size was small, the data are encouraging and support the planned initiation of a Phase III trial in the coming months. This interview took place at the 77th American Academy of Neurology (AAN) Annual Meeting in San Diego, CA.
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Transcript
So the study for bemdaneprocel was a Phase I open label and it’s primarily a two-year study. The safety and efficacy were looked at sort of separately. So safety and tolerability were the primary endpoints at one year and the study met the safety and tolerability endpoints. In terms of efficacy, those are mostly secondary clinical evaluations, secondary endpoints that we looked at...
So the study for bemdaneprocel was a Phase I open label and it’s primarily a two-year study. The safety and efficacy were looked at sort of separately. So safety and tolerability were the primary endpoints at one year and the study met the safety and tolerability endpoints. In terms of efficacy, those are mostly secondary clinical evaluations, secondary endpoints that we looked at. And for the most part, there was either stability or some positive signals. But again, it was a small sample size. So when you’re evaluating motor and non-motor outcomes in Parkinson’s and such a small sample, one or two patients can really skew things. But overall, it was either no worse or maybe some signs of improvement or some trends in improvement, particularly in patients who got the higher dose of the cell therapy. So all of it is exciting and reassuring and we’ll be proceeding with the Phase III trial shortly in the next few months.
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Disclosures
I received research support for my work on clinical trials from Biogen, Meira GTX, Sun Pharma, Bukwang, Genentech, Prevail, BlueRock, Neuroderm, UCB, Cerevance and Novo Nordisk.
