BioVie Inc. (NASDAQ: BIVI) announced it has fully enrolled its ADDRESS-LC Phase 2 trial evaluating bezisterim for treating neurological symptoms associated with long COVID. The company expects to release topline data in late summer 2026.

The randomized, placebo-controlled trial is comparing bezisterim, administered as a 20 mg oral capsule twice daily, against placebo in adult participants with long COVID who experience cognitive impairment and fatigue. The study is fully funded by a $13.13 million grant from the U.S. Department of War through the Peer-Reviewed Medical Research Program.

The primary endpoint measures changes in performance on a Cogstate Cognitive Battery designed to assess neurocognitive symptoms. Secondary endpoints include patient-reported outcomes for cognitive function, fatigue, sleep disturbance, and post-exertional malaise.

"The full enrollment of the ADDRESS-LC trial marks an important milestone for BioVie, and we look forward to reporting topline data later this summer," said Cuong Do, president and CEO of BioVie.

According to the company, an estimated 15 million U.S. adults reported having long COVID between 2022 and 2023, with 3.8 million experiencing significant limitation to their daily lives. The condition currently has no FDA-approved treatment options.

Bezisterim is an investigational oral drug that crosses the blood-brain barrier and targets neuroinflammation pathways. BioVie is also studying the compound in Parkinson's disease and Alzheimer's disease trials.

The Carson City, Nevada-based clinical-stage biopharmaceutical company focuses on developing therapies for neurological disorders and advanced liver disease.