Bezisterim (NE3107) - (ADDRESS-LC)

September 15, 2026: BioVie Inc. (NASDAQ: BIVI) reported topline Phase 2 ADDRESS-LC (NCT06847191) results for bezisterim (NE3107) in Long COVID. In the 203-patient randomized, double-blind, placebo-controlled study, no endpoint reached statistical significance in the overall intent-to-treat population, although 21 of 22 endpoints numerically favored bezisterim.

In pre-specified subgroup analyses submitted to FDA before unblinding, patients with higher baseline symptom burden showed statistically significant benefits. The most severe half of patients with fatigue had significant improvement on five endpoints, including 3 of 5 fatigue-specific measures, with trends in post-exertional malaise and sleep. Patients with high post-exertional malaise had significant improvements across malaise, fatigue, and objective cognitive measures. Patients with substantial objective cognitive impairment showed significant improvement on four objective cognitive endpoints. The company said these findings are exploratory and require confirmation in an adequately powered prospective study.

Safety and tolerability were similar to placebo: treatment-emergent adverse events occurred in 41.6% of bezisterim patients versus 55.9% on placebo; headache was 4.0% vs. 4.9%; no serious adverse events occurred with bezisterim versus one on placebo. BioVie said the data support planning a future Phase 3 trial.