BioVie fully enrolls 200-patient Long COVID Phase 2 trial with $13.13M DoW grant
BIVI•BioVie has fully enrolled 200 participants in its ADDRESS-LC Phase 2 trial of bezisterim for Long COVID neurological symptoms, supported by a $13.13 million DoW grant. Topline data are due late summer 2026, with primary endpoints measuring cognitive improvements on the Cogstate battery and secondary endpoints covering fatigue, sleep and quality-of-life scores.
1. Enrollment Milestone
BioVie has reached full enrollment of 200 participants in the ADDRESS-LC trial evaluating twice-daily 20 mg bezisterim for Long COVID neurological symptoms. Recruitment was completed under the Department of War grant, marking a pivotal step toward data analysis.
2. Trial Design and Endpoints
The randomized 1:1, placebo-controlled, multicenter study will assess cognitive improvements via the Cogstate Cognitive Battery as the primary endpoint and track fatigue, sleep disturbance and quality-of-life changes through PROMIS, SF-12 and DePaul scales.
3. Grant Funding and Next Steps
The $13.13 million award fully funds the study under the Peer-Reviewed Medical Research Program, with topline results expected late summer 2026. Successful data could position bezisterim as the first FDA-approved Long COVID therapy, driving BioVie’s clinical and commercial prospects.
