BioVie Completes Phase 2 Trial for Long COVID Treatment, Awaits Results
Event summary
- BioVie completed the treatment phase of its ADDRESS-LC Phase 2 trial for bezisterim, a treatment for neurological symptoms of Long COVID.
- The trial, fully funded by a $13.13 million grant from the U.S. Department of War, enrolled approximately 200 patients.
- Topline results are expected before the end of September 2026.
- Bezisterim targets neuroinflammation and insulin resistance, with potential applications in Parkinson’s, Alzheimer’s, and Long COVID.
The big picture
BioVie’s completion of the ADDRESS-LC trial marks a critical step in addressing the unmet medical need for Long COVID treatments. With an estimated 17-20 million U.S. adults affected, the trial’s results could position bezisterim as a leading therapeutic option. The strategic focus on neuroinflammation aligns with broader industry trends in targeting inflammatory pathways for neurological disorders.
What we're watching
- Clinical Efficacy
- Whether bezisterim demonstrates significant efficacy in reducing Long COVID symptoms, particularly brain fog and fatigue.
- Regulatory Pathway
- The pace at which BioVie can advance bezisterim through further trials and potential FDA approval.
- Market Opportunity
- How BioVie positions bezisterim in the broader market for Long COVID treatments, given the lack of current FDA-approved options.