Bayer has shared the positive details of a small phase 1 Parkinson’s disease trial of an investigational cellular therapy developed by its U.S. subsidiary BlueRock.
The German drugmaker had briefly teased the trial's success back in June, but presented the full data at the recent International Congress of Parkinson's Disease and Movement Disorders in Copenhagen.
According to Bayer, bemdaneprocel was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts. At one-year, exploratory clinical endpoints improved overall, with participants in the high dose cohort showing greater improvement. Specifically, using the Hauser Diary, which categorizes patients as being in the 'ON' state when their symptoms are well controlled and in the 'OFF' state when they experience a worsening of symptoms, participants in the high dose cohort showed an improvement of 2.16 hours in the 'ON' state compared with baseline after one year. Time spent in the 'OFF' state showed a decrease of 1.91 hours after one year.
Bemdaneprocel is designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic stem cells. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to reform neural networks that have been severely affected by Parkinson’s and restore motor and non-motor function to patients.
According to the drugmaker, planning is underway for a phase 2 study that is expected to begin enrolling participants in the first half of 2024.
Bemdaneprocel is BlueRock's lead clinical program. The company, which focuses on developing engineered cell therapies in the fields of neurology, cardiology and immunology using a proprietary induced pluripotent stem cell platform, was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. In 2019, Bayer paid $600 million to take full control of BlueRock, making it a wholly owned independent subsidiary.