BioVie Inc. is leveraging its experience in neuroinflammation to target the Long COVID market with bezisterim, an oral anti-inflammatory agent already in trials for Alzheimer’s and Parkinson’s disease. The company announced the design of its ongoing Phase 2 ADDRESS-LC trial, which is noteworthy for its patient-centric features and enrichment strategy. The trial is fully funded by a $13.13 million grant from the Department of Defense.
The ADDRESS-LC trial is designed to evaluate bezisterim’s efficacy, safety, and tolerability in adults with Long COVID-related cognitive impairment and fatigue. The study incorporates pragmatic elements based on patient feedback, stratifying participants by symptom duration (less than or greater than/equal to two years) and age (18–45 or 46–64). This stratification acknowledges the potential for refractory symptoms and age-related cognitive differences.
The core strategy appears to be two-fold. First, BioVie seeks to capitalize on the significant unmet need in the Long COVID market, where millions experience persistent neurological symptoms without FDA-approved treatments. Second, by using a drug candidate already undergoing clinical investigation for other neurodegenerative diseases, the company can leverage existing safety and tolerability data, potentially accelerating the development timeline. The use of a bespoke Cogstate Cognitive Battery as a key endpoint allows for objective measurement of neurocognitive improvements, addressing a critical challenge in Long COVID research.
The trial’s design has implications for several stakeholders. For patients, it offers a potential new treatment option for debilitating symptoms. For BioVie, positive results could validate its platform approach and open a significant new market. For research sites, the trial’s pragmatic design, including remote assessments, could improve recruitment and retention. The DoD’s funding signals growing recognition of Long COVID’s societal impact.
Looking ahead, the trial’s success hinges on demonstrating a statistically significant improvement in cognitive function and fatigue. The stratified analysis will be crucial, potentially revealing whether bezisterim is more effective in specific Long COVID subpopulations. Competition is likely to intensify as other companies target this large market. BioVie’s ability to differentiate bezisterim, potentially through demonstration of disease-modifying effects or impact on specific biomarkers, will be crucial for long-term success. The trial’s outcome could also inform the development of future Long COVID therapies, particularly those targeting neuroinflammation.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
