BlueRock Phase I Trial: Positive 18-Month Data for Parkinson's Treatment

Photo:Representative Image

Bayer AG and BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, announced details of 18-month data from the phase I clinical trial for bemdaneprocel, an investigational allogeneic stem cell-derived cell therapy for treating Parkinson’s disease. The data were presented at the Alzheimer’s and Parkinson’s Diseases Conference in Lisbon, Portugal.

The data demonstrate that at 18 months, bemdaneprocel continues to be well tolerated with no major safety issues, transplanted cells survive and engraft in the brain, and the F-DOPA signal continues to increase after stopping immune suppression therapy at 12 months as outlined in the study’s protocol.

In addition, exploratory clinical endpoints improved compared to baseline assessments in both cohorts, with participants in the high-dose cohort showing greater improvement than those in the low-dose cohort. These were assessed by the MDS-Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) and the Hauser Diary, which are tools used to assess Parkinson’s disease severity in motor symptoms.

“It’s exciting that bemdaneprocel met safety and tolerability criteria at 12 months, and now the 18-month results suggest that these allogeneic cells survive and have potentially positive effects even after discontinuation of immunosuppressants,” said Claire Henchcliffe, MD, chair of the UCI School of Medicine Department of Neurology at the University of California, Irvine and one of the study’s Principal Investigators. “We should not overinterpret the results of a phase I study, but this is a promising step that deserves to be followed up with further studies.”

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 their symptoms, participants in the high dose cohort showed a mean increase of 2.7 hours in time spent in the “Good ON” state time compared with baseline after 18 months. Time spent in the “OFF” state showed a mean decrease of 2.7 hours after 18 months. For participants in the low-dose group, "positive ON" time improved by 0.2 hours compared to baseline, and "OFF" time decreased by an average of 0.8 hours.

In the high-dose group, 18 "Months of Bemdaneprocel efficacy using the MDS-UPDRS Part 3, measured in OFF" - showed a mean decrease of 23 points compared to the on-treatment sequence. The low-dose group showed little improvement, with an average reduction of 8.6 points.