BioVie’s Bezisterim Shows Mixed Phase 2 Long COVID Results

BioVie Inc. (NASDAQ: BIVI) reported results from its Phase 2 ADDRESS-LC trial evaluating bezisterim for treating long COVID, a condition affecting an estimated 17–20 million U.S. adults with no FDA-approved therapies. The trial enrolled 203 patients and assessed the drug’s impact on neurological symptoms such as fatigue, brain fog, cognitive impairment, and post-exertional malaise. Overall, the intent-to-treat population did not achieve statistical significance on any endpoint, though numerical trends favored treatment over placebo across 21 of 22 individual measures. However, prespecified subgroup analyses revealed meaningful differences in patient subgroups with greater baseline symptom burdens—representing about 78% of participants—where the drug demonstrated statistically significant improvements in multiple endpoints. Notably, the most severe half of patients with fatigue showed benefits on five endpoints, while those with high post-exertional malaise and substantial cognitive impairment experienced statistically significant improvements across malaise, fatigue, and objective cognitive measures. Safety data indicated a similar adverse-event profile between bezisterim and placebo, with no serious adverse events reported in the treatment arm and a slightly lower incidence of treatment-emergent events (41.6% vs. 55.9%). The trial was fully funded by a $13.13 million grant from the U.S. Department of Defense’s Peer-Reviewed Medical Research Program. BioVie plans to advance to a Phase 3 confirmatory trial, aiming to solidify the drug’s potential as a long COVID treatment.