BlueRock Therapeutics has treated the first patient in its Phase III exPDite-2 trial of bemdaneprocel, an investigational cell therapy for Parkinson’s disease, according to the company. The therapy, derived from allogeneic pluripotent stem cells, is designed to replace dopamine-producing neurons lost in the disease.
The exPDite-2 trial is a randomized, sham surgery-controlled, double-blind study evaluating the safety and efficacy of bemdaneprocel. The study will enroll approximately 102 participants and track changes in motor and non-motor symptoms, daily living activities, and quality of life over 78 weeks, the company said.
BlueRock claims that prior Phase I data with 12 participants showed bemdaneprocel was well tolerated, with no serious adverse events linked to the therapy at 24 months post-surgery, and noted encouraging trends in motor function improvements.
The investigational therapy has received Fast Track and Regenerative Medicine Advanced Therapy designations from the U.S. Food and Drug Administration, the company said. Results from exPDite-2 could support regulatory submissions for marketing authorization, depending on the trial outcomes.
Parkinson’s disease is a progressive neurodegenerative disorder affecting more than 10 million people worldwide, characterized by loss of motor function and non-motor symptoms such as cognitive issues and fatigue. Current treatments are largely symptomatic, highlighting the need for innovative therapies, according to BlueRock.
BlueRock Therapeutics, a clinical-stage subsidiary of Bayer AG, focuses on developing cell therapies for neurological and ophthalmic diseases. Bemdaneprocel is among its leading investigational programs currently in clinical development.
