Bezisterim (NE3107) - (ADDRESS-LC)

May 26, 2026: BioVie Inc. (NASDAQ: BIVI) announced full enrollment of its ADDRESS-LC Phase 2 randomized (1:1), placebo-controlled, multicenter trial of bezisterim (NE3107) for neurological symptoms of Long COVID (cognitive impairment sequelae and fatigue). The study (approximately 200 patients) is fully funded by a $13.13 million U.S. Department of War grant (PRMRP Award No. HT9425-24-1-0113). Bezisterim is administered as a 20 mg oral capsule twice daily. The primary endpoint is change in performance on a Cogstate Cognitive Battery; secondary endpoints include PROMIS Cognitive Function/Fatigue/Sleep Disturbance, SF-12 physical and mental component scores, and the DePaul Symptom Questionnaire post-exertional malaise domain. Topline data are expected in late summer 2026 (also referenced as “later this summer”).

Other upcoming catalyst noted: SUNRISE-PD (Parkinson’s disease) has completed enrollment (60 patients) evaluating bezisterim in patients not treated with carbidopa/levodopa; topline results are expected in calendar Q3 2026.