Bayer: towards a Phase III study in Parkinson's disease

(CercleFinance.com) - Bayer announced on Monday that its subsidiary BlueRock Therapeutics plans to start a Phase III clinical trial of bemdaneprocel in the treatment of Parkinson's disease in the coming months.


The trial, which is due to start by the end of the first half of the year, aims to recruit 102 participants with a moderate form of the disease.

The aim is to assess the efficacy, safety and wider impact of this experimental cell therapy, which replaces the dopamine-producing neurons destroyed in the course of the disease.

Stem cell-derived neurons are surgically implanted into the brain to restructure the affected neural networks and restore motor and non-motor functions.

The primary endpoint is to be based on the absence of problematic dyskinesias (involuntary, abnormal, jerky movements) after 78 weeks of treatment.

Last year, Bayer received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for bemdaneprocel in the treatment of Parkinson's disease.

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