BioVie Presents Proposed Phase 3 Trial Design for Bezisterim in Parkinson's Disease

• BioVie outlined a proposed 160-patient Phase 3 trial of bezisterim in early Parkinson's disease, with a six-month primary endpoint.
• The trial would use MDS-UPDRS Total Score as its primary endpoint, enrolling 100 patients with higher baseline platelet counts.
• Among 57 Phase 2b participants, MDS-UPDRS total scores favored bezisterim but did not reach statistical significance (p=0.4491).
• A higher-platelet subgroup of 27 patients showed a larger total-score treatment effect, with Cohen's d of -1.45 (p=0.0011).
• Bezisterim had no treatment-related discontinuations; the trial recorded no serious or severe adverse events or deaths.

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