BlueRock Therapeutics reports positive 18-month data from phase I trial for bemdaneprocel in Parkinson’s disease

Bayer AG and BlueRock Therapeutics LP, an independently operated subsidiary of Bayer AG, have disclosed 18-month data from a phase I clinical trial on bemdaneprocel, an investigational allogeneic stem cell-derived therapy for Parkinson's disease. Presented at the Alzheimer’s and Parkinson’s Diseases Conference in Lisbon, Portugal, the data show continued tolerability of bemdaneprocel, with transplanted cells surviving and engrafting in the brain. Notably, the F-DOPA signal increased after the cessation of immune suppression therapy at 12 months. Exploratory endpoints improved compared to baseline in both high and low-dose cohorts, particularly in the high-dose group. Assessments included the MDS-Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) and the Hauser Diary, evaluating motor symptoms. Further clinical testing via a phase II study is scheduled to commence later this year.

Bemdaneprocel (BRT-DA01) aims to replace lost dopamine-producing neurons in Parkinson's disease, derived from human embryonic stem cells. The therapy, administered via surgical implantation, holds promise in rebuilding neural networks and restoring function. The phase I trial, involving 12 subjects, assessed safety, cell survival, and motor effects over 18 months. Parkinson's disease, characterized by dopamine depletion, results in progressive motor dysfunction.