Bayer AG and BlueRock Therapeutics, a subsidiary of Bayer, announced positive 24-month data from exPDite, a Phase 1 trial of bemdaneprocel, an investigational cell therapy for Parkinson’s disease. Bemdaneprocel is the most advanced cell therapy in the U.S. for Parkinson’s, and the trial aimed to assess its safety and tolerability. The data will be presented at the International Congress of Parkinson’s Disease and Movement Disorders in September 2024.
“We are excited to share that bemdaneprocel shows promise as a meaningful treatment option for Parkinson’s,” said Amit Rakhit, Chief Development Officer at BlueRock. “This study marks an important milestone and sets the stage for further development.”
The 24-month safety profile remained consistent, with no adverse events linked to bemdaneprocel. Transplanted cells survived and engrafted in the brain after stopping immunosuppression therapy at 12 months. Positive trends in motor symptom improvements were seen, particularly in the high dose cohort, as measured by the MDS-UPDRS scale and the Hauser PD Diary. These results suggest sustained benefits for movement impairments.
Claire Henchcliffe, MD, one of the study’s investigators, said, “The study demonstrates cell survival and early signs of motor symptom control, indicating bemdaneprocel’s potential. Further placebo-controlled studies are warranted.”
In the high dose group, motor symptoms showed a mean reduction of 21.9 points on the MDS-UPDRS scale, compared to 8.3 points in the low dose group. Patients in the high dose cohort also spent 1.8 more hours in the “Good ON” state and 1.9 fewer hours in the “OFF” state, as per the Hauser PD Diary.
Christian Rommel, Head of R&D at Bayer Pharmaceuticals, added, “These results support our commitment to developing innovative therapies for Parkinson’s patients.
