Berlin, Germany and Cambridge, M.A., U.S.A., June 28, 2023 – Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, today announced positive top-line results from a Phase I clinical trial of investigational drug, bemdaneprocel (BRT-DA01), a potential first-in-class cell therapy for Parkinson’s disease. The trial showed that bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events. In addition, an assessment of the study’s secondary endpoints demonstrated feasibility of transplantation and evidence of cell survival and engraftment in the brain through one year. Based on these results, planning is underway for a Phase II study that is expected to begin enrolling patients in H1 (first half) 2024.
- Investigational Bemdaneprocel (BRT-DA01) was well tolerated with no major safety issues in all 12 patients through one year
- Assessment of secondary endpoints demonstrates feasibility of transplantation and evidence of cell survival and engraftment
- Phase II clinical study expected to begin enrolling patients in H1 2024
- Detailed Phase I trial data from primary and secondary endpoints will be presented at the 2023 International Congress on Parkinson’s Disease and Movement Disorders taking place in Copenhagen from August 27-31