BioVie seeks FDA end-of-Phase 2 meeting to advance bezisterim Phase 3 Parkinson’s trial design - BIVI News | RalliesBioVie seeks FDA end-of-Phase 2 meeting to advance bezisterim Phase 3 Parkinson’s trial design
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BIVI• FDA meeting sought for Phase 3 Parkinson’s trial design
- BioVie opened the next stage of FDA engagement to advance a Phase 3 program for bezisterim in Parkinson’s disease.
- Phase 3 design centers on improving motor symptoms, with non-motor symptom benefit positioned as a key co-primary or secondary outcome.
- Earlier Phase 2 results have already been presented, suggesting stronger overall symptom improvement in patients with higher inflammation.
- The strategy could support a Phase 3 study of about 175 patients, using an enrichment approach to target likely responders.
- BioVie expects FDA discussion later this fall, with formal written feedback anticipated before year-end.
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