Bayer has early evidence that its Parkinson’s disease cell therapy is safe. Now, with a phase 2 clinical trial on course to open enrollment next year, the German drugmaker is set to start showing whether the candidate can undo damage and restore motor function.
The cell therapy, bemdaneprocel, is in development at Bayer’s BlueRock Therapeutics subsidiary. In 2021, BlueRock began enrolling patients in a phase 1 clinical trial to test the safety and tolerability of surgically transplanting dopamine-producing cells in the brains of people with Parkinson’s. The goal was to look at the rate of serious adverse events and abnormal tissue overgrowth in the year after transplantation.
Bemdaneprocel passed the safety and tolerability test. Bayer saw no major safety issues in the first year of the 12-subject clinical trial. Analysis of secondary endpoints showed the feasibility of transplantation and provided evidence of cell survival and engraftment in the brain.
Bayer and BlueRock are holding off on sharing a closer look at the data until an event in late August.
“The safety profile of bemdaneprocel was encouraging along with early evidence of cell survival and engraftment, marking a very important step in the development of a potential new therapy for patients with this disease,” Ahmed Enayetallah, M.D., Ph.D., senior vice president and head of development at BlueRock, said in the release. “These topline data provide a strong rationale for initiating the next phase study, and we look forward to advancing this clinical program.”
Bayer and BlueRock plan to start enrolling subjects in a phase 2 clinical trial in the first half of next year. The midstage study will mark a ratcheting up of the push to show whether bemdaneprocel can reform neural networks and restore motor functions in Parkinson’s, as Bayer hopes, and represent an early test of the broader idea of using the pluripotent stem-cell-based platform to address major unmet medical needs.
Bayer has pursued that idea for several years now, partnering with Versant Ventures to get BlueRock going with a $225 million series A round in 2016 and paying $240 million to buy the biotech three years later.