Bayer Cell therapy for Parkinson's Disease: Positive Results in the First Phase I Clinical Trial

2023-06-30

On June 28th, Bayer Group and its independently operated clinical phase cell therapy subsidiary BlueRock Therapeutics LP announced that the phase I clinical trial of the research drug bemdaneprocel (BRT-DA01) had achieved positive results. Bemdaneprocel (BRT-DA01) is a potential first Cell therapy for Parkinson's disease. Experiments have shown that to date, bemdaneprocel has shown good tolerance among all 12 patients in the study, and no major safety events have occurred. In addition, the evaluation of the secondary endpoint of this study demonstrated the feasibility of transplantation, as well as evidence of cell survival and one-year implantation in the brain. Based on these results, the Phase II clinical trial of this study is currently being planned and it is expected to begin recruiting patients in the first half of 2024. "Our mission is to use the power of Cell therapy to help Parkinson's patients regain control of their lives by restoring their lost functions," said Ahmed Enayetallah, senior vice president and development director of BlueRock Therapeutics. "The early evidence of Bemdaneprocel is encouraging, which marks a very critical step for us to develop potential new therapies for patients with Parkinson's disease. These important data provide a strong basis for starting the next stage of research. We look forward to advancing this clinical plan." Parkinson's disease is a progressive neurodegenerative disease, which is caused by brain nerve cell damage, and can lead to the reduction of dopamine levels. At the time of diagnosis, the patient may have lost 50-80% of dopaminergic neurons. The loss of neurons can lead to a gradual loss of motor function and symptoms such as tremors, muscle stiffness, and motor disorders. Bemdaneprocel (BRT-DA01) is a research-based therapy composed of dopaminergic neurons produced by pluripotent stem cells that can be implanted into the brain of Parkinson's disease patients through surgery. After transplantation, these cells may potentially reshape the neural network damaged by Parkinson's disease, with the potential to restore patients' motor and non motor functions. "At Bayer, we are committed to promoting the innovation of cell and gene therapy for patients with Parkinson's disease. Parkinson's disease is a neurodegenerative disease, which has a serious impact on people's lives. At present, there is no cure method, and treatment options are very limited," said Christian Rommel, member of the executive committee of Bayer Prescription Medicine Division and the global head of research and development. The first clinical trial of cell therapy for Parkinson's disease has achieved positive results, not only injecting a strong needle into the development plan of bemdaneprocel, but also inspiring our entire platform based on pluripotent stem cells, proving that it is worth further research in a larger patient population. Detailed Phase I trial data for the main and secondary endpoints of the above study will be announced at the International Conference on Parkinson's Disease and Movement Disorders in 2023. The conference will be held from August 27th to 31st in Copenhagen, Denmark.

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