Bayer and BlueRock Report Positive 36-Month Phase I Data for Bemdaneprocel in Parkinson’s Disease

Bayer AG and its wholly owned subsidiary BlueRock Therapeutics LP, a clinical-stage cell therapy company, announced positive 36-month results from exPDite, a Phase I clinical trial evaluating bemdaneprocel (BRT-DA01), an investigational cell therapy for Parkinson’s disease (PD). The data were presented on October 6 at the International Congress of Parkinson’s Disease and Movement Disorders.

Promising Long-Term Results

After three years of follow-up, bemdaneprocel continues to demonstrate a favorable safety profile and encouraging clinical trends:

• Well tolerated: No therapy- or surgery-related adverse events were reported.
• Durable cell survival: F-Dopa imaging confirmed that transplanted cells survived and engrafted in the brain even after immunosuppression therapy ended at 12 months.
• Sustained clinical benefit: Positive trends in motor function and daily living persisted through 36 months, with stronger effects observed in the high-dose cohort.

Motor symptom improvements were assessed using the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III and the Parkinson’s Disease Diary.

Clinically Meaningful Reductions in Motor Symptoms

In the high-dose cohort (n=7), patients experienced a mean reduction of 17.9 points on the MDS-UPDRS Part III (“OFF”-medication state) compared to baseline. The low-dose cohort (n=4) showed a 13.5-point reduction, both considered clinically meaningful improvements.

Key findings from the Parkinson’s Disease Diary include:

• High-dose cohort:
  - “Good ON” time (symptom-controlled without troublesome dyskinesias) increased by 1 hour
  - “OFF” time decreased by 0.93 hours
• Low-dose cohort:
  - “Good ON” time increased by 0.23 hours
  - “OFF” time decreased by 1.15 hours

For activities of daily living (MDS-UPDRS Part II), the high-dose cohort improved by –4.3 points, while the low-dose group showed a modest 0.2-point increase. Participants from both groups continue in the long-term Continued Evaluation Study.

Expert Commentary

Dr. Claire Henchcliffe, Chair of Neurology at UC Irvine and study Principal Investigator, stated:

“Bemdaneprocel represents a new approach to restoring the dopamine inputs lost in Parkinson’s. The three-year data are an important next step for long-term safety assessment. While we must remain cautious, positive clinical signals—especially in the higher dose group—are encouraging.”

Dr. Gabi Belfort, Senior Vice President and bemdaneprocel Product Lead at BlueRock Therapeutics, added:

“These results reinforce our belief that bemdaneprocel may become a meaningful, durable treatment option for people living with Parkinson’s disease. We’re eager to advance to the next stage of clinical testing.”

Dr. Christian Rommel, Global Head of R&D, Bayer Pharmaceuticals, said:

“This milestone strengthens our commitment to developing transformative therapies for Parkinson’s disease, where unmet need remains extremely high.”

About Bemdaneprocel (BRT-DA01)

Bemdaneprocel is an investigational cell therapy designed to replace dopamine-producing neurons lost in Parkinson’s disease. These dopaminergic neuron precursors, derived from human embryonic pluripotent stem cells, are implanted into the brain, where they can mature and re-establish neural networks affected by Parkinson’s.
The goal: to restore both motor and non-motor function.

Regulatory designations:

• Fast Track Designation (2021)
• Regenerative Medicine Advanced Therapy (RMAT) designation (2024) from the U.S. FDA

A pivotal Phase III trial comparing bemdaneprocel to sham surgery control is currently enrolling participants.

About Parkinson’s Disease

• A progressive neurodegenerative disorder affecting over 10 million people globally
• Caused by the loss of dopamine-producing nerve cells in the brain
• Symptoms: tremors, rigidity, slowness of movement, fatigue, cognitive decline, and depression
• The second most prevalent neurodegenerative disease worldwide and the most common movement disorder
• Current treatments manage symptoms but do not halt disease progression, underscoring the need for new therapeutic options

About BlueRock Therapeutics

BlueRock Therapeutics LP is a clinical-stage cell therapy company focused on developing cellular medicines for neurological and ophthalmic diseases. The company aims to transform care for patients suffering from devastating neurodegenerative conditions.

About Bayer

Bayer is a global life sciences company with core competencies in healthcare and nutrition. Guided by its mission — “Health for all, Hunger for none” — Bayer develops innovations to help people and the planet thrive amid a growing, aging population.

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