BioVie's Bezisterim Shows Mixed Results in Long COVID Phase 2 Trial
Event summary
- BioVie to host conference call on September 15, 2026, to discuss topline Phase 2 ADDRESS-LC trial results for bezisterim in Long COVID.
- Trial enrolled approximately 200 patients, evaluating 22 clinical outcome measures without a pre-specified primary endpoint.
- Bezisterim is an oral drug targeting neuroinflammation and insulin sensitivity, with potential applications in Parkinson’s, Long COVID, and Alzheimer’s.
- Trial funded by a $13.13 million grant from the U.S. Department of War (DoW).
- Phase 2 trial did not achieve statistical significance in the overall intent-to-treat population; subgroup analyses showed potential signals.
The big picture
BioVie’s Phase 2 trial results for bezisterim in Long COVID highlight the challenges of developing treatments for complex, heterogeneous conditions like Long COVID. The mixed results—with no statistical significance in the overall population but potential signals in subgroups—reflect the broader industry trend of needing larger, more targeted trials to validate early signals. The strategic focus on neuroinflammation and insulin sensitivity positions BioVie in a growing market for neurological and neurodegenerative disease treatments, but the path to regulatory approval remains uncertain.
What we're watching
- Subgroup Analysis Validity
- Whether the statistically significant results observed in pre-specified subgroup analyses can be replicated in future trials.
- Regulatory Pathway
- The FDA has not validated the endpoints used in this trial as surrogate endpoints for Long COVID, which could impact future approval efforts.
- Funding and Development
- The pace at which BioVie can secure additional funding to advance bezisterim through potentially pivotal Phase 3 trials.