BlueRock Therapeutics announces publication in Nature of 18-month data from Phase I clinical trial for bemdaneprocel, an investigational cell therapy for Parkinson’s disease
BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, announced the publication of the 18-month data from its Phase I exPDite clinical trial for bemdaneprocel (NCT04802733)) in the journal Nature. The publication, which is available online (see citation), confirms that 18 months following surgery, treatment with bemdaneprocel did not cause any serious adverse events related to cell therapy. In addition, positron emission tomography (PET) imaging techniques demonstrated sustained neuron cell engraftment in the trial’s high and low dose cohorts following discontinuation of immunosuppression after one year post-treatment. The publication also reports encouraging trends in secondary and exploratory subjective and objective endpoints related to motor function. These data were first presented in March 2024 at the Alzheimer’s and Parkinson’s Diseases Conference in Lisbon.
The Phase III trial, called exPDite-2, is expected to be started in the first half of 2025.
“The concept of “rebuilding” brain networks that have been lost to disease is compelling,” said Dr. Claire Henchcliffe, chairwoman of the UC Irvine School of Medicine’s Department of Neurology at the University of California, Irvine and one of the study’s Principal Investigators, “The results of this early phase clinical trial demonstrate the promise of regenerative medicine and should provide hope for Parkinson’s disease patients and their families.”
"Cell therapy is a potential new treatment option for individuals with Parkinson’s disease and our team is immensely proud of having bemdaneprocel’s 18-month Phase 1 data published in such a prestigious journal as Nature,” said Dr. Amit Rakhit, Head of Development and Chief Medical Officer at BlueRock Therapeutics. “Our efforts are now focused on maintaining our forward momentum to initiate and enroll the Phase 3 trial as we advance bemdaneprocel’s development to this exciting next stage.”
See citation- Tabar V., Sarva H., Lozano AM. et al. Phase I trial of hES cell-derived dopaminergic neurons for Parkinson’s disease. Nature 2025. https://doi.org/10.1038/s41586-025-08845-y
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