BioVie completes enrollment in Phase 2 Long COVID trial
Published: 09:12 26 May 2026 EDT
BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) said on Tuesday it has completed enrollment in its ADDRESS-LC Phase 2 clinical trial evaluating bezisterim for the treatment of neurological symptoms of Long COVID, with topline data expected later this summer.
The trial, fully funded by a grant from the US Department of War, is testing whether bezisterim can address neurological and neuropsychiatric symptoms associated with Long COVID, including fatigue, cognitive dysfunction, post-exertional malaise and sleep disturbance.
An estimated 15 million US adults reported having Long COVID between 2022 and 2023, with 3.8 million experiencing significant limitation to their daily lives. No FDA-approved treatments currently exist for the condition.
Cuong Do, President and CEO of BioVie, said the completed enrollment marked an important milestone for the company. “The evolving scientific understanding and growing body of research surrounding Long COVID continue to reinforce the rationale for bezisterim’s proposed mechanism, particularly its modulation of inflammatory pathways associated with neurocognitive and neuropsychiatric symptoms.”
Chronic neuroinflammation is among the leading hypotheses for the persistence of Long COVID symptoms, with recent evidence showing ongoing neuroinflammation in affected individuals compared to healthy controls.
Penelope Markham, senior vice president of liver disease and Long COVID programs at BioVie, credited trial participants, clinical investigators, site staff and advocacy partners including SolveME and the Patient-Led Research Collaborative for supporting enrollment in the study.
BioVie is a clinical-stage company developing drug therapies for neurological and neurodegenerative diseases.
