On August 28th, Bayer Group and its independently operated clinical phase cell therapy subsidiary BlueRock Therapeutics LP released detailed information on the positive results of the phase I clinical trial of the research drug bemdaneprocel (BRT-DA01). Bemdaneprocel is a stem cell derived therapy for Parkinson's disease. The above data was announced at the International Conference on Parkinson's Disease and Movement Disorders held in Copenhagen, Denmark. The main objective of this study was to demonstrate the safety and tolerability of bemdaneprocel in all 12 subjects in the low-dose and high-dose groups, and no serious adverse events related to the therapy were reported within one year. In addition, 18F-DOPA PET imaging scans showed evidence of cell survival and implantation in both low-dose and high-dose groups. 18F-DOPA PET imaging is a neuroradiological technique used to visualize and evaluate dopamine activity in Parkinson's disease. The World Association of Motion Disorders Parkinson's Disease Comprehensive Evaluation Scale MDS-UPDRS Part 3 (motor function examination) and the motor function status assessment tool Hauser Diary showed improvement in secondary exploratory clinical endpoints in both groups, with subjects in the high-dose group showing greater improvement. Dr. Claire Henchcliffe, Dean of the School of Neurology at the University of California, Irvine, and one of the main researchers of the study, said, Although this is a small open label study, the achievement of its primary endpoint confirms the safety and tolerability of the treatment, and the initial improvement shown in clinical results represents a significant step forward in the study. We hope that this trend can continue and translate into benefits for Parkinson's disease patients in subsequent clinical controlled trials. "Using Hauser Diary to classify patients, The patient's "open" state indicates that their symptoms have been well controlled; In the "off" state, it indicates that the symptoms have worsened. Compared to baseline, the high-dose group of participants in the Bendaneprocel Phase I clinical trial had an additional 2.16 hours of "on" status after one year and did not experience any movement disorders; The time in the 'off' state was correspondingly reduced by 1.91 hours. The low-dose group of participants spent 0.72 hours in the "on" state compared to the baseline, and did not experience any movement disorders. The time in the "off" state was correspondingly reduced by 0.75 hours. In the high-dose group, the Parkinson's Disease Rating Scale MDS-UPDRS was used to score the one-year efficacy of bemdaneprocel in the "discontinued" state, resulting in a 13.0 point decrease compared to baseline. The low-dose group resulted in a 7.6 point decrease from baseline. To help patients suffering from Parkinson's disease, we need innovative therapies. "Ahmed Enayetallah, Senior Vice President and Development Director, BlueRock Therapeutics
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