Bayer Advances Dual Therapies for Parkinson’s Disease

Bayer Advances Dual Therapies for Parkinson’s Disease

By, Admin 23 September 2025

Bayer has taken a bold step in Parkinson’s research. The company launched major trials for two investigational therapies: a cell therapy and a gene therapy.

exPDite-2: Phase III Trial of Bemdaneprocel

The first participant has been randomized in the pivotal phase III exPDite-2 trial.

  • Bemdaneprocel (BRT-DA01) is an investigational cell therapy.
  • It uses dopaminergic neuron precursors from human embryonic pluripotent stem cells.
  • These cells are implanted into the brain and can mature into dopamine-producing neurons.
  • The therapy aims to restore motor and non-motor functions by re-forming damaged neural networks.

Bemdaneprocel has Fast Track Designation and RMAT designation from the FDA.
In a phase I trial, 12 participants showed good tolerability at 24 months post-surgery, with no serious adverse events. Encouraging trends in motor function were also observed.

The exPDite-2 trial is multicenter, double-blind, and sham-controlled. It will enroll about 102 patients.

  • Primary endpoint: Change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia.
  • Secondary endpoints: Objective movement measures, non-motor symptoms, safety, daily living, and quality of life.

REGENERATE-PD: Phase II Trial of AB-1005

In parallel, Bayer started the REGENERATE-PD trial in Europe.

  • AB-1005 is an investigational gene therapy based on AAV2 vector delivering the GDNF transgene.
  • It enables continuous expression of GDNF in the brain after neurosurgical injection with MRI-monitored delivery.
  • GDNF supports survival and differentiation of dopaminergic neurons.

The trial will enroll 87 participants across Germany, Poland, the UK, and the U.S.
It is randomized, double-blind, and surgery-controlled, targeting adults aged 45–75 with moderate Parkinson’s disease.

Why This Matters

Parkinson’s disease affects over 10 million people worldwide. Prevalence has doubled in 25 years, making it the second most common neurodegenerative disease and the most frequent movement disorder.

Symptoms include tremors, rigidity, slow movement, fatigue, depression, and cognitive decline. Current treatments manage symptoms but fail to stop disease progression.

Bayer’s Strategy

Bayer’s dual approach—cell and gene therapy—maximizes chances of delivering disease-modifying treatments.

  • BlueRock Therapeutics leads bemdaneprocel development.
  • AskBio leads AB-1005.
  • Bayer provides global infrastructure and state-of-the-art manufacturing facilities.

Christian Rommel, Bayer’s head of R&D, said the company aims to set a benchmark in cell and gene therapy.

Voices from Development

  • BlueRock’s Gabi Belfort emphasized the potential of replacing lost dopamine-producing neurons with bemdaneprocel.
  • AskBio’s Adrian Kells highlighted the importance of testing AB-1005 as a neurorestorative option for patients.

Next Steps

Both bemdaneprocel and AB-1005 are investigational. Safety and efficacy are still under evaluation, with no regulatory approvals yet.

Still, Bayer’s progress represents a new frontier in Parkinson’s therapy, offering hope for millions waiting for effective treatment.

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