BioVie Inc. (BIVI), a clinical-stage biopharmaceutical company, on Tuesday reported complete enrollment in the Phase 2 ADDRESS-LC trial for Bezisterim in treating neurological symptoms of Long COVID.
Long COVID has affected around 15 million people in the U.S. alone, and manifests with neurological symptoms like fatigue, cognitive dysfunction, post-exertion malaise, and sleep disturbances. There are currently no FDA-approved medications for the treatment of the disease.
Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain-barrier to modulate key pathways in neuroinflammation and is currently being advanced for the treatment of Long COVID, Alzheimer's and Parkinson's disease.
The Phase 2 ADDRESS-LC trial is a randomized, placebo-controlled, multicenter study funded entirely by the U.S. Department of War (DoW). The trial is evaluating the safety and efficacy of bezisterim in treating neurocognitive and fatigue-related symptoms of long COVID. The drug is administered in a twice-daily oral dose, with the primary endpoint set at an improvement in neurocognition, measured by the Cogstate Cognitive Battery objective tool.
The Phase 2 SUNRISE-PD trial evaluating Bezisterim in combination with levodopa for the treatment of Parkinson's disease has been completed, with topline results expected in the third quarter of this year.
BIVI is currently trading at $1.46, down 3.95%.
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