BlueRock announces first patient enrolled in exPDite-2 Phase III trial

BlueRock Therapeutics (Bayer)/Bemdaneprocel

First patient randomized and treated in exPDite-2, the first controlled Phase III trial of a pluripotent stem cell-derived dopaminergic therapy for Parkinson's. The randomized, sham-controlled study will enroll ~102 patients.

• ExPDite-2: randomized, double-blind, sham-controlled Phase III trial in moderate Parkinson's.
• ~102 patients; primary completion target March 2027; final completion March 2032.
• Primary endpoint: ON-time without troublesome dyskinesia at week 78.
• Phase I showed no serious adverse events at 24 months post-surgery; encouraging motor trends.