Berlin, Germany, Cambridge, MA, USA, August 28, 2023 — Bayer AG and BlueRock Therapeutics LP, a scientific phase cell treatment business and entirely owned individually run subsidiary of Bayer AG, revealed today information of the favorable information from the Phase I scientific trial for bemdaneprocel (BRT-DA01), a stem cell obtained investigational treatment for dealing with Parkinson’s illness. The information existed at the International Congress of Parkinson’s Disease and Movement Disorders® in Copenhagen, Denmark.
The research study fulfilled the main goal of showing security and tolerability in all 12 individuals in the research study’s low and high dosage accomplices, without any major unfavorable occasions (SAEs) reported associated to bemdaneprocel through one year. There were 2 SAEs reported that were unassociated to bemdaneprocel, one seizure credited to the surgery and one COVID case. Both dealt with without sequelae. In addition, 18F-DOPA PET imaging scans shown proof of cell survival and engraftment in both low and high dosage mates. 18F-DOPA PET imaging is a neuroradiological method utilized to imagine and evaluate dopaminergic activity in Parkinson’s illness.
Secondary exploratory medical endpoints enhanced in both associates, with individuals in the high dosage associate revealing higher enhancement, as evaluated by the MDS-Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) and the Hauser Diary, which are tools utilized to evaluate Parkinson’s illness seriousness in motor signs.
“The information from this Phase I open label research study are incredibly motivating,” stated Claire Henchcliffe, MD, chair of the UCI School of Medicine Department of Neurology at the University of California, Irvine and among the research study’s Principal Investigators. “While this is a little open label research study, fulfilling the research study’s main unbiased for security and tolerability together with preliminary enhancements seen in medical results represents a fantastic advance. The hope now is that these patterns continue and equate into significant advantage for individuals with Parkinson’s illness in regulated scientific trials.”
Utilizing the Hauser Diary, which classifies clients as remaining in the “ON” state when their signs are well managed and in the “OFF” state when they experience a worsening of their signs, individuals in the high dosage mate revealed an enhancement of 2.16 hours in time invested in the “ON” state without unpleasant dyskinesia compared to standard after one year. Time invested in the “OFF” state revealed a matching reduction of 1.91 hours after one year. Individuals in the low dosage accomplice revealed an enhancement of 0.72 hours in the “ON” state without unpleasant dyskinesia time compared to standard and a matching decline of 0.75 hours in “OFF” state time.
In the high dosage friend, a 1 year measurement of the results of bemdaneprocel utilizing MDS-UPDRS Part III determined in the “OFF”-medication state, revealed a decrease of 13.0 points compared to standard. The low dosage mate revealed a decrease of 7.6 points.
“The requirement for brand-new treatments to assist clients battling with Parkinson’s illness is clear,” stated Ahmed Enayetallah, Senior Vice President and Head of Development, BlueRock Therapeutics. “We are delighted to be sharing the outcomes of this Phase I and anticipate advancing bemdaneprocel to the next phase of medical screening.”
Based upon these outcomes, preparation is underway for a Phase II research study that is ex