Statistically significant benefits observed in bezisterim-treated Long COVID patients
in pre-specified subgroups with high baseline fatigue, cognitive impairment, and/or post‑exertional malaise
Bezisterim showed a consistent advantage over placebo on 21 out of 22 individual endpoints in the overall study population
An estimated 17–20 million U.S. adults live with Long COVID and currently have no FDA‑approved treatment options
Conference call scheduled for 8:30 a.m. today, September 15, 2026, to discuss results.
CARSON CITY, Nev., Sept. 15, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced topline results from the Company’s Phase 2 ADDRESS-LC trial (NCT06847191) evaluating its investigational drug candidate bezisterim, an oral drug that crosses the blood-brain barrier and is believed to reduce inflammation and improve insulin sensitivity, in Long COVID. In pre-specified subgroup analyses submitted to the FDA prior to data unblinding, patients with greater baseline burden on one or more symptoms (approximately 78% of trial participants) demonstrated statistically significant improvements on multiple clinically coherent endpoints. Bezisterim’s safety and tolerability profile was similar to placebo.