newsfilter
← Latest News
GlobeNewswire·

BioVie Announces Full Enrollment of the ADDRESS-LC Trial of Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID

BIVI
  • BioVie Inc. announced full enrollment of its Phase 2 ADDRESS-LC trial evaluating bezisterim for Long COVID neurological symptoms.
  • The trial is fully funded by a $13.13 million grant from the U.S. Department of War (formerly Department of Defense).
  • Topline data from the ADDRESS-LC trial is targeted for release in late summer 2026.
  • Approximately 200 adult participants with cognitive impairment sequelae & fatigue were enrolled in the randomized, placebo-controlled study.
  • The primary endpoint measures changes in performance on a bespoke Cogstate Cognitive Battery to assess neurocognitive improvements.
  • Secondary endpoints include patient-reported outcomes such as PROMIS Cognitive Function, Fatigue, Sleep Disturbance, SF-12 scores, & the DePaul Symptom Questionnaire.
  • Bezisterim (NE3107) is an oral drug designed to cross the blood-brain barrier, modulate inflammatory pathways (ERK, NFκB, TNF-α), & improve insulin sensitivity.
  • BioVie expects bezisterim to reduce symptoms potentially triggered by persistent spike protein fragments causing neuroinflammation.
  • In Parkinson's disease, the SUNRISE-PD study has completed enrollment of 60 patients, with top-line results expected in Q3 2026.
  • No FDA-approved therapies currently exist for Long COVID, which affects an estimated 15 million U.S. adults with significant disability in millions of cases.
  • The study received support from advocacy partners including SolveME & the Patient-Led Research Collaborative (PLRC).
  • BioVie is also advancing BIV201 for liver cirrhosis complications following receipt of FDA Orphan & Fast Track designations.