BlueRock Therapeutics reports positive 36-month results from Phase I trial of bemdaneprocel for treating Parkinson’s disease

Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy company, today announced positive 36-month data from exPDite, a Phase I clinical trial of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson's disease (PD). The data were presented on October 6th at the International Congress of Parkinson’s Disease and Movements Disorders.

“Bemdaneprocel represents a new approach to restoring the dopamine inputs that are lost in Parkinson’s, and leverages substantial advances in stem cell technology,” said Claire Henchcliffe, MD, chair of the UC Irvine School of Medicine’s Department of Neurology at the University of California, Irvine and one of the study’s Principal Investigators. “The new 3-year data is a critical next step to evaluate longer term safety. While there is a need for caution in interpreting the positive trends in clinical outcomes, initial signals are there, particularly in the higher dose cohort and the upcoming exPDite-2 clinical trial should shed further light on potential benefits.”

Bemdaneprocel’s safety profile at 36 months is consistent with earlier findings, demonstrating that it continues to be well tolerated by patients, with no adverse events reported related to the therapy or surgical procedure. F-Dopa imaging suggests that transplanted cells continue to survive and engraft in the brain after discontinuing immunosuppression therapy at 12 months as outlined in the study’s protocol. In addition, secondary clinical endpoints related to motor symptoms continue to show positive trends from baseline through the duration of follow-up, with more encouraging trends in the high dose cohort than those in the low dose cohort. These were assessed by the MDS-Unified Parkinson’s Disease Rating Scale Part II and III (MDS-UPDRS Part II & III) and the Parkinson’s disease Diary, tools used to assess Parkinson’s disease severity in motor symptoms.

“The 36-month data from this Phase I study underscores our hope that bemdaneprocel could be a potentially meaningful and durable therapeutic option for treating people living with Parkinson’s disease,” said Gabi Belfort, MD, PhD, Senior Vice President and Bemdaneprocel Product Lead at BlueRock Therapeutics. “We are excited to share these data with the Parkinson’s disease community and are committed to advancing bemdaneprocel through the next stage of clinical testing.”