BERLIN, Germany and CAMBRIDGE, MA, USA I March 6, 2024 I Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today 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 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 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. Participants in the low dose cohort showed a mean improvement of 0.2 hours in the “Good ON” state time compared with baseline and a corresponding mean decrease of 0.8 hours in “OFF” state time.

In the high dose cohort, an 18-month measurement of the effects of bemdaneprocel using MDS-UPDRS Part III measured in the “OFF”-medication state, showed a mean reduction of 23 points compared with baseline. The low dose cohort showed a mild improvement, with a mean decrease of 8.6 points.

“We are excited to see the continued positive trends in the data from bemdaneprocel’s phase I trial at 18 months,” said Ahmed Enayetallah, Senior Vice President and Head of Development at BlueRock Therapeutics. “While it is still early days and there is more work to do, we look forward to further investigating bemdaneprocel in clinical studies.”

A phase II study for further clinical testing of bemdaneprocel is planned to begin enrolling patients later this year.

“We are on the leading edge in the research for new treatment options for Parkinson’s disease as bemdaneprocel, the most clinically advanced pluripotent stem derived cell therapy candidate to date for this disease, continues to show positive trends,” said Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “There are good reasons to be optimistic about these early data, and we are excited to move to phase II later this year.”

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