BlueRock Therapeutics, a subsidiary of Bayer AG, has announced positive 24-month data from its Phase I clinical trial, exPDite, evaluating BRT-DA01 (bemdaneprocel) for Parkinson's disease. The investigational cell therapy aims to replace dopamine-producing neurons damaged by the disease, potentially restoring motor function.
The data, presented at the International Congress of Parkinson’s Disease and Movement Disorders, indicated that bemdaneprocel was well-tolerated, with no reported adverse events. Notably, transplanted cells continued to survive in the brain after immunosuppression was discontinued at 12 months. Motor symptom improvements, particularly in the high-dose cohort, suggest sustained benefits for movement impairments associated with Parkinson’s disease.
Phase I Trial Details
The Phase I trial, exPDite, assessed the safety and preliminary efficacy of BRT-DA01 in patients with Parkinson's disease. Bemdaneprocel is a cell therapy utilizing stem cell-derived dopamine-producing neurons. The primary endpoint focused on safety and tolerability, while secondary endpoints included assessments of motor function using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III and the Hauser Parkinson’s Disease Diary.
Clinical Significance
"We are very excited to share the 24-month data from the exPDite trial, which shows that bemdaneprocel could be a potentially meaningful treatment option for individuals living with Parkinson’s disease," said Amit Rakhit, Chief Development and Medical Officer at BlueRock Therapeutics. "The completion of this study marks an important milestone for bemdaneprocel and sets the stage for the next phase of clinical development."
Future Directions
These promising Phase I results pave the way for further clinical development of bemdaneprocel. BlueRock Therapeutics is planning to initiate Phase II trials to further evaluate the efficacy and safety of this cell therapy in a larger patient population. If successful, bemdaneprocel could represent a significant advancement in the treatment of Parkinson's disease, addressing the unmet need for therapies that can restore lost motor function.
