Business UpdateAug 13, 2026, 06:08 AM
BioVie's Parkinson's Drug Meets Phase 2b Primary Endpoint
AI Summary
BioVie Inc. provided comprehensive updates on its clinical programs, highlighting positive Phase 2b results for bezisterim in Parkinson's disease, which met its primary endpoint and showed clinical improvements. The company also secured a $13.1 million grant for its Long COVID program, with Phase 2 trial results anticipated in late summer 2026. While the Alzheimer's disease Phase 3 trial faced challenges due to protocol deviations, the BIV201 program for liver cirrhosis showed promising Phase 2 data and is progressing towards Phase 3, supported by FDA Fast Track and Orphan Drug designations. The company continues to expand its intellectual property portfolio for both bezisterim and BIV201.
Key Highlights
- Bezisterim's Phase 2b Parkinson's trial met primary endpoint with statistically significant neuroinflammation reduction (p=0.0018).
- Parkinson's trial showed improvements in EPNIC-15 composite endpoint (p=0.0006) and neurodegeneration biomarkers.
- Long COVID program received a $13.1 million grant from the U.S. Department of War for its Phase 2 ADDRESS-LC study.
- Long COVID Phase 2 trial completed enrollment in May 2026, with topline results expected late summer 2026.
- BIV201 Phase 2 data showed over 30% reduction in ascites fluid; Phase 3 protocol is being finalized.
- BIV201 holds FDA Fast Track status and Orphan Drug designation for ascites, targeting a >$650 million market.
- Bezisterim (NE3107) has 12 issued U.S. patents and 4 issued foreign patents protecting its compounds and methods.
- BIV201 liquid formulation patents are granted in 7 countries, with expiration dates extending to 2040-2043.
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