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 was fully funded by a $13.13 million grant from the U.S. Department of War (DoW).
- Topline results are expected before the end of September 2026.
- The trial enrolled approximately 200 patients with Long COVID experiencing cognitive impairment and fatigue.
- 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 milestone in the search for Long COVID treatments, an area with significant unmet medical need. With an estimated 17-20 million U.S. adults affected, the trial’s results could validate bezisterim’s mechanism of action in modulating neuroinflammation, potentially opening doors to broader applications in neurodegenerative diseases. The strategic backing from the DoW underscores the urgency and importance of addressing Long COVID, positioning BioVie at the forefront of this emerging therapeutic landscape.
What we're watching
- Clinical Efficacy
- Whether bezisterim demonstrates significant efficacy in reducing Long COVID symptoms, particularly brain fog and fatigue, which could position it as a first-of-its-kind treatment.
- Regulatory Pathway
- The pace at which BioVie can advance bezisterim through subsequent clinical trials and potential FDA approval, given the current lack of approved treatments for Long COVID.
- Market Opportunity
- How BioVie leverages the $13.13 million DoW grant to support further development and commercialization efforts, particularly in expanding bezisterim’s applications beyond Long COVID.