The biotech subsidiary BlueRock will start a phase 3 clinical study of the cell therapy Bemdaneprocel, as the Leverkusen-based pharmaceutical and agricultural group announced on Monday. This study will follow directly on from the phase 1 study after discussion of the data with the US Food and Drug Administration (FDA). It is expected to start in the first half of this year and will include around 102 participants with moderate Parkinson's disease.
Bayer secured the treatment with its full acquisition of BlueRock in 2019. According to the companies, the planned study will be the first phase 3 study of an allogeneic pluripotent stem cell-derived therapy for Parkinson's disease. Bemdaneprocel aims to replace the dopamine-producing neurons lost in Parkinson's disease. These neurons are derived from pluripotent stem cells that originate from human embryonic stem cells. They are implanted in the brains of Parkinson's patients, where they have the potential to regenerate damaged neural networks and restore motor and non-motor functions.
In the phase 1 study with twelve participants, it was shown that Bemdaneprocel was well tolerated even 24 months after surgery. Parkinson's disease is the most common neurodegenerative movement disorder, affecting more than ten million people worldwide. It is caused by damage to the nerve cells in the brain, which leads to a deficiency of the messenger substance dopamine. Existing medications can alleviate the symptoms, but a cure is not yet available.
(Report by Patricia Weiß, edited by Sabine Wollrab. If you have any questions, please contact our editorial team at berlin.newsroom@thomsonreuters.com (for politics and business cycles) or frankfurt.newsroom@thomsonreuters.com (for companies and markets).)