Bayer AG (OTC:BAYRY) (OTC:BAYZF) and its subsidiary BlueRock Therapeutics LP announced topline results from a Phase 1 trial of bemdaneprocel (BRT-DA01), an investigational cell therapy for Parkinson’s disease.
Parkinson’s disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. According to the Parkinson’s Foundation, more than 10 million people worldwide have Parkinson’s disease, with approximately one million living in the U.S.
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Bemdaneprocel, comprised of dopamine-producing neurons derived from pluripotent stem cells, is surgically implanted into the brain of a person with Parkinson’s disease.
When transplanted, these cells have the potential to reform neural networks that Parkinson’s disease has destroyed in the hope of restoring motor and non-motor function in patients.
The trial showed that bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events.
In addition, an assessment of the study’s secondary endpoints demonstrated the feasibility of transplantation and evidence of cell survival and engraftment in the brain through one year.
Based on these results, planning is underway for a Phase 2 study that is expected to begin enrolling patients in H1 (first half) 2024.
Detailed Phase 1 trial data from primary and secondary endpoints will be presented at the 2023 International Congress of Parkinson’s Disease and Movement Disorders in August.
