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BioVie Selected for Late-Breaking Oral Presentation of Bezisterim Long COVID Data at the 4th Long COVID International Conference 2026

BIVI
  • BioVie Inc. (NASDAQ: BIVI) will present late-breaking oral data on bezisterim at the 4th Long COVID International Conference 2026 in Nice, France, on November 13, 2026.
  • Dr. Penelope Markham, Senior Vice President & Program Lead for Long COVID, will present findings titled "Bezisterim Improves Fatigue, Post-Exertional Malaise, and Cognition in Prespecified High-Symptom-Burden Subgroups of the Phase 2 Randomized ADDRESS-LC Trial in Long COVID."
  • The presentation will include new, previously unshared biomarker data that supports clinical findings from the ADDRESS-LC trial.
  • The Phase 2 ADDRESS-LC trial showed bezisterim had a consistent trend toward improvement across efficacy measures compared to placebo, with statistically significant benefits observed in pre-specified subgroups exhibiting severe baseline fatigue, post-exertional malaise (PEM), or cognitive impairment.
  • Approximately 78% of trial participants experienced at least one of the severe baseline symptoms targeted in the subgroup analysis.
  • The ADDRESS-LC study is a randomized, placebo-controlled, signal-seeking trial fully funded by a $13.13 million grant from the U.S. Department of War (DoW) under Award No. HT9425-24-1-0113.
  • The trial enrolled approximately 200 patients receiving 20 mg of bezisterim twice daily to assess neurocognitive & fatigue-related symptoms using 22 clinical outcome measures.
  • The study did not achieve statistical significance on any endpoint in the overall intent-to-treat population; significant results were limited to pre-specified subgroup analyses.
  • Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier to reduce inflammation & improve insulin sensitivity without suppressing the immune system.
  • BioVie is also evaluating bezisterim for Parkinson's disease (based on SUNRISE-PD trial results) & Alzheimer's disease (based on Phase 2 & 3 trial data).
  • No FDA-approved treatments currently exist for Long COVID, an estimated 17-20 million U.S. adults live with the condition.
  • BioVie is advancing BIV201 (terlipressin infusion) for advanced liver cirrhosis, which holds FDA Orphan & Fast Track designations.