BlueRock publishes 18-month data on allogeneic cell therapy in Parkinson’s disease

BlueRock Therapeutics, a wholly owned subsidiary of Bayer, has published 18-month data from its phase 1 clinical trial for its stem cell therapy, bemdaneprocel, for Parkinson’s disease.

According to BlueRock, bemdaneprocel is the first investigational allogeneic pluripotent stem cell-derived cell therapy for Parkinson’s disease and the most clinically advanced cell therapy being investigated for treating the disease. The therapy was first developed at Memorial Sloan Kettering Cancer Center and then licensed to BlueRock.

The 12-patient exPDite clinical trial, published in Nature, achieved its primary objectives of safety and tolerability one year after transplantation, with no adverse events related to the cell product. At 18 months after grafting, putaminal 18Fluoro-DOPA positron emission tomography uptake increased, indicating graft survival. Secondary and exploratory clinical outcomes showed improvement or stability, including improvement in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III OFF scores by an average of 23 points in the high-dose cohort.

As previously shared, BlueRock expects to initiate the phase 3 trial, exPDite-2, in the first half of 2025.  The registrational trial will enroll approximately 102 participants with moderate Parkinson’s disease. The double-blind trial will assess the efficacy, safety and overall impact of bemdaneprocel compared to a sham surgery control. The primary endpoint of the study is change from baseline to week 78 in Parkinson’s diary measure of “ON-time” without troublesome dyskinesia (movement disorders), adjusted for a 16-hour waking day.