Bayer has made a significant advancement in Parkinson’s disease treatment with the launch of a pivotal phase 3 clinical trial. The study will assess the efficacy of Bemdaneprocel, a cell therapy developed by Bayer’s biotech subsidiary, BlueRock Therapeutics. The announcement was made by Bayer on Monday.
This phase 3 study follows the completion of a phase 1 trial and builds on discussions held with the U.S. Food and Drug Administration (FDA) regarding the collected data. The trial is expected to commence in the first half of 2025, involving approximately 102 participants with moderate Parkinson’s disease.
Bayer secured the rights to Bemdaneprocel following its full acquisition of BlueRock in 2019. The upcoming trial is notable as it will be the first phase 3 study to explore an allogeneic pluripotent stem cell-derived therapy for Parkinson’s disease. The therapy aims to address the underlying causes of the condition by replacing lost dopamine-producing neurons. These neurons are derived from human embryonic stem cells and implanted in the brain, with the potential to regenerate damaged neural networks, restoring both motor and non-motor functions.
Initial results from the phase 1 study, which included twelve participants, indicated that Bemdaneprocel was well tolerated, with no significant issues observed even 24 months post-surgery. Parkinson’s disease, the most common neurodegenerative movement disorder, currently affects over 10 million people globally. The disease is characterized by the degeneration of nerve cells in the brain, leading to a dopamine deficiency. While current treatments help alleviate symptoms, no cure is yet available.
The new phase 3 trial could represent a major step toward finding a viable cure for Parkinson’s disease, offering hope to millions of patients worldwide.
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