Bayer details early success with cell therapy for Parkinson's
28 Aug 2023
Clinical ResultPhase 1Cell Therapy
Bayer and its BlueRock Therapeutics subsidiary on Monday detailed positive data from a Phase I trial of their investigational stem cell-derived therapy bemdaneprocel for the treatment of Parkinson's disease. Based on the results, the companies reiterated that preparations are underway for a Phase II study that is expected to begin enrolling patients in the first half 2024.
In the open-label, non-randomised Phase I study, 12 subjects received surgical transplantation of one of two different dose levels of bemdaneprocel cells to the post-commissural putamen bilaterally. A one-year immunosuppression regimen was also given. Cohort A included five patients who received a dose of 0.9 million cells per putamen, while Cohort B had seven subjects who received 2.7 million cells per putamen. Safety and tolerability were assessed at one year, along with evidence of cell survival and motor effects.
The detailed findings were presented at the International Congress of Parkinson's Disease and Movement Disorders. The study met the primary objective of safety and tolerability in all 12 participants across both cohorts, with no serious adverse events (SAEs) related to bemdaneprocel through one year. There were two SAEs reported that were unrelated to bemdaneprocel, with one being a seizure attributed to the surgical procedure, although the companies said both SAEs resolved without sequelae. They also noted that 18F-DOPA positron emission tomography (PET) scans showed evidence of cell survival and engraftment in both low- and high-dose cohorts.
Longer time with well-controlled symptoms
Meanwhile, secondary exploratory endpoints improved in both cohorts, with high-dose participants showing greater benefit, based on a pair of tools used to assess Parkinson's severity in motor symptoms. Within the high dose-cohort, the one-year evaluation of bemdaneprocel's impact using MDS-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) while in the OFF-medication state indicated a decline of 13 points compared to baseline. In the low-dose cohort, a reduction of 7.6 points was observed.
Using the Hauser Diary, those in the high-dose cohort showed an improvement of 2.16 hours in time spent in the ON state without troubling dyskinesia, compared with baseline after one year, while time spent in the OFF state showed a corresponding decrease of 1.91 hours. Meanwhile, the low-dose cohort showed an improvement of 0.72 hours in the ON state without troubling dyskinesia time, compared with baseline, and a corresponding decrease of 0.75 hours in OFF state time.
"The positive outcome of this Phase I clinical trial is a clear step forward," remarked Christian Rommel, Bayer's head of drug R&D. Bemdaneprocel, also known as BRT-DA01, is designed to replace dopaminergic neuron precursors that are lost in Parkinson's patients. The neuron precursors are surgically implanted into the brain to restore neural networks destroyed by the disease.
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