Clinical TrialAug 6, 2026, 07:41 AM
BioVie bezisterim Phase 2 Parkinson's trial shows significant improvements
AI Summary
BioVie Inc. announced positive topline results from its Phase 2 SUNRISE-PD trial for bezisterim in early-stage Parkinson's disease. The drug candidate demonstrated statistically significant improvements in both motor and non-motor symptoms, as well as beneficial impacts on neurodegeneration and inflammation biomarkers. Bezisterim was well-tolerated with a safety profile comparable to placebo, and the company plans to use these findings to inform the design of a potentially pivotal Phase 3 trial.
Key Highlights
- Bezisterim showed statistically significant improvements in motor and non-motor symptoms.
- EPNIC-15 composite endpoint: bezisterim -0.04 vs placebo +0.18 (p=0.0006).
- Reduced neuro- and systemic-inflammation biomarkers, including CCL2, CHI3L1, VGF.
- Composite neuroinflammation measure: -0.28 for bezisterim vs +0.19 for placebo (p=0.0018).
- 283 of 380 proteins shifted favorably, suggesting slowing of disease progression.
- Improved neurodegeneration biomarkers (NfL, GFAP, UCHL1, BN02, MAPT).
- Composite neuronal injury signal: -0.09 for bezisterim vs +0.06 for placebo (p=0.043).
- Adverse event incidence: 39.3% for bezisterim vs 51.7% for placebo.
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