Key points from article :
Bayer and BlueRock Therapeutics announced positive results from a Phase I trial of investigational drug, bemdaneprocel (BRT-DA01).
Comprised of dopamine producing neurons derived from pluripotent stem cells.
Bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events.
When transplanted, these cells reform neural networks in the hope of restoring motor and non-motor function to patients.
Secondary endpoints showed feasibility of transplantation and evidence of cell survival and engraftment in the brain through one year.
Planning is underway for a Phase II study that is expected to begin enrolling patients in H1 (first half) 2024.
“The safety profile was encouraging...marking the development of a potential new therapy for patients with Parkinson’s disease,” said Ahmed Enayetallah, Senior Vice President and Head of Development, BlueRock Therapeutics.
“The positive outcome is encouraging not only for the development program but also entire pluripotent stem cell-based platform and warrants further investigation in larger groups of patients.” ,” said Christian Rommel, Head of R&D at Bayer.
