BioVie's Bezisterim Shows Promise in Long COVID Phase 2 Trial
Event summary
- BioVie's Phase 2 ADDRESS-LC trial showed statistically significant benefits for bezisterim in treating Long COVID neurological symptoms in high-baseline-subgroups.
- 21 of 22 endpoints favored bezisterim over placebo in the overall study population, though none reached statistical significance.
- The trial enrolled 203 patients, with 78% showing high baseline fatigue, cognitive impairment, or post-exertional malaise.
- Bezisterim demonstrated a favorable safety profile, with similar adverse event rates to placebo.
The big picture
BioVie's positive Phase 2 results for bezisterim in Long COVID come as the field struggles with a lack of approved treatments for the estimated 17–20 million U.S. adults living with the condition. The trial's focus on high-symptom-burden patients aligns with growing recognition of Long COVID's heterogeneity, potentially offering a precision-medicine approach. If confirmed in Phase 3, bezisterim could become the first therapy targeting neurological symptoms of Long COVID, addressing a significant unmet medical need.
What we're watching
- Regulatory Pathway
- Whether the exploratory subgroup findings will support a Phase 3 trial design acceptable to the FDA.
- Competitive Landscape
- How BioVie positions bezisterim against potential future Long COVID therapies given the lack of current FDA-approved treatments.
- Execution Risk
- The pace at which BioVie can advance bezisterim through clinical development while managing its other pipeline programs.