Bezisterim (NE3107) - (ADDRESS-LC)

Aug. 31, 2026: BioVie Inc. (NASDAQ: BIVI) said the last on-treatment visit has been completed in ADDRESS-LC, its randomized, placebo-controlled Phase 2 trial of bezisterim (NE3107) for neurological symptoms of Long COVID, with one-month virtual follow-up nearly complete. The company said it expects topline results before the end of September 2026.

ADDRESS-LC is a multicenter proof-of-concept study in approximately 200 adults with Long COVID, cognitive impairment sequelae, and fatigue. It compares bezisterim 20 mg orally twice daily versus placebo, with endpoints including overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, quality of life, and post-exertional malaise. The trial is fully funded by a $13.13 million U.S. Department of War award under the PRMRP.

Bezisterim is described as an investigational oral drug that crosses the blood-brain barrier and modulates inflammatory pathways. The release also notes prior SUNRISE-PD trial topline results in early Parkinson’s disease showed improvements in inflammatory blood markers and multiple clinical measures versus placebo. BioVie also said it plans a Phase 3 trial of BIV201 in cirrhosis and ascites.