BioVie Completes SUNRISE-PD Phase 2b Trial, Topline Data Due Q3 2026
BioVie completed last patient evaluation in its 57-patient SUNRISE-PD Phase 2b trial of bezisterim for early-stage Parkinson’s disease and will start closeout procedures. Topline efficacy and safety data are expected in Q3 2026 following evaluation of motor, non-motor, and biomarker endpoints.
1. Completion of Last Patient Evaluation
BioVie completed the final patient evaluation visit in its SUNRISE-PD Phase 2b trial testing bezisterim in early-stage Parkinson’s disease patients who had not received levodopa. The company will commence study closeout and prepare for data unblinding later this year.
2. Trial Design and Endpoints
SUNRISE-PD enrolled 57 patients in a 20-week randomized, double-blind, placebo-controlled design with bezisterim 20 mg twice daily. The trial assessed a predefined battery of motor and non-motor endpoints—including UPDRS I–III, PDQ, PDSS, and CGI scales—and plasma biomarkers of inflammation and neurodegeneration.
3. Next Steps and Data Timeline
BioVie targets Q3 2026 for topline efficacy and safety data release to inform the design of Phase 3 registrational trials. The results will evaluate bezisterim’s therapeutic impact and its potential to modulate neuroinflammation and insulin resistance pathways in Parkinson’s disease.