GERMANY — A groundbreaking cell therapy designed to combat Parkinson’s disease has achieved promising results in an early-stage clinical trial, as announced by its developer, Bluerock Therapeutics.
The therapy, known as bemdaneprocel, holds the potential to transform the lives of Parkinson’s patients and represents a significant advancement in the quest for effective treatments.
Bluerock Therapeutics, a subsidiary of the renowned German pharmaceutical giant Bayer, conducted an experimental study that has yielded encouraging outcomes.
The therapy, derived from stem cells, demonstrated a remarkable safety profile and tolerability among the 12 patients who received it.
Notably, there were only two serious adverse events reported, both of which were deemed unrelated to the treatment.
The study involved the administration of both low and high doses of bemdaneprocel, with compelling evidence indicating that the cells successfully engrafted and survived in both groups.
Furthermore, researchers explored whether the therapy had an impact on the progression of Parkinson’s itself.
Remarkably, Bluerock reported that one year after treatment, patients in the high-dose group displayed the most significant improvement in disease severity.
A hidden epidemic unveiled
Estimates suggest that nearly half a million individuals in the United States are affected by Parkinson’s disease.
However, due to underdiagnosis and misdiagnosis, some experts believe that the actual number may be considerably higher.
This debilitating ailment leads to the degeneration or impairment of nerve cells in the brain region responsible for controlling movement.
The primary treatment approach for Parkinson’s currently revolves around dopamine, a vital chemical messenger involved in various essential functions, particularly motor control.
Bluerock’s innovative therapy targets dopamine in a novel manner, aiming to replace the dopamine-producing nerve cells lost in Parkinson’s patients.
Promising outcomes and improved quality of life
As part of the bemdaneprocel study, participants tracked their “on” and “off” states, indicating periods of well-controlled symptoms and moments of symptom exacerbation, respectively.
Remarkably, one year after receiving the treatment, individuals in the high-dose group reported an increase of slightly over two hours in their “on” state without troublesome involuntary movements. Simultaneously, they experienced a reduction of just under two hours in their “off” state.
Dr. Claire Henchcliffe, one of the principal investigators of the study and the chair of the neurology department at the University of California, Irvine School of Medicine, expressed her optimism: “The data collected for bemdaneprocel is extremely encouraging.
“While this is a small open-label study, meeting the study’s primary objective for safety and tolerability along with initial improvements seen in clinical outcomes represents a great step forward. The hope now is that these trends continue and translate into meaningful benefit for people with Parkinson’s disease in controlled clinical trials.”
A promising path ahead
Buoyed by the promising results thus far, Bluerock is planning to embark on a mid-stage study, expected to commence enrollment in the first half of the upcoming year.
This next phase of research holds the potential to bring us closer to a game-changing therapy for Parkinson’s disease.
Bluerock Therapeutics, established in late 2016 as a collaborative venture between Bayer and investment firm Versant Ventures, has been at the forefront of pioneering cell therapy.
In 2019, Bayer solidified its commitment by acquiring all remaining equity in Bluerock for an initial sum of US$240 million, with the potential for an additional US$360 million based on developmental milestones.
Since the acquisition, Bluerock has continued to operate as an autonomous subsidiary of Bayer, championing the cause of cell therapy.
Bayer’s continued investments in this field underscore its dedication to advancing medical breakthroughs.
Notably, in 2021, Bayer’s venture arm led a US$105 million funding round for Senti Biosciences, a California-based biotechnology company focused on developing “off-the-shelf” cellular medicines for cancer.
While the acquisition of rights to experimental cell therapies from Atara Biotherapeutics has faced challenges, Bayer remains committed to the quest for innovative treatments.
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