BioVie presents proposed Phase 3 trial design for bezisterim in Parkinson's disease
BIVI•BioVie outlined a proposed 160-patient Phase 3 trial of bezisterim in early Parkinson's disease, with a six-month primary endpoint. In a 27-patient subgroup with higher baseline platelet counts, Phase 2b results showed a treatment effect of Cohen's d -1.45 (p=0.0011).
1. Proposed Phase 3 design
BioVie outlined a proposed 160-patient Phase 3 trial of bezisterim in early Parkinson's disease, with a six-month primary endpoint measured by MDS-UPDRS Total Score. The trial would enroll 100 patients with higher baseline platelet counts.
2. Phase 2b results
Among 57 Phase 2b participants, MDS-UPDRS total scores favored bezisterim but did not reach statistical significance (p=0.4491). In the 27-patient higher-platelet subgroup, the total-score treatment effect was Cohen's d -1.45 (p=0.0011). BioVie reported no treatment-related discontinuations, serious or severe adverse events, or deaths.
