BioVie Presents Data on Bezisterim in Long COVID at the 2026 American Neurological Association Annual Meeting
Key Highlights
- ➤Phase 2 ADDRESS-LC enrolled 203 patients; 22 exploratory endpoints had no prespecified primary endpoint
- ➤PROMIS Fatigue improved 8.93 versus 5.30 points with placebo among most fatigued patients (p=0.02)
- ➤No endpoint achieved statistical significance in the overall intent-to-treat population
- ➤Bezisterim adverse events occurred in 41.6% versus 55.9% for placebo; no serious events reported
- ➤Long COVID study received a fully funded $13.13 million Department of War award
Expert Statements
Penelope Markham, BioVie’s Senior Vice President and Program Lead for Long COVID
“These results highlight the substantial heterogeneity of Long COVID and suggest that baseline disease burden may play an important role in identifying patients most likely to benefit from treatment with bezisterim. We observed a consistent and clinically meaningful pattern of improvement across measures of fatigue, post-exertional malaise, clinician- and patient-reported outcomes, and objective measures of cognition function among patients with greater baseline symptom burden. We believe these findings provide an important foundation for the design of a confirmatory Phase 3 study.”
CARSON CITY, Nev., Oct. 19, 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 the presentation of results from the Phase 2 ADDRESS-LC study (NCT06847191) evaluating bezisterim (NE3107) in patients with Long COVID at the 151st Annual Meeting of the American Neurological Association (ANA), held October 17–20, 2026, in San Diego, California. The study’s abstract was published in Annals of Neurology (Vol. 100, pp. S4–S375, https://doi.org/10.1002%2Fana.78378), in conjunction with the meeting.
The poster, “Results of a Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Bezisterim (NE3107) in Long COVID (ADDRESS-LC),” detailed findings from the randomized, double-blinded, placebo-controlled signal-finding ADDRESS-LC trial (NCT06847191) (link). Patients (n=203) received bezisterim or placebo for 12 weeks to evaluate whether bezisterim could improve key neurological symptoms of Long COVID, including fatigue, brain fog, subjective and objective cognitive impairment, and post-exertional malaise (PEM), as well as safety and tolerability. The ADDRESS-LC trial explored 22 different measures to assess clinical outcomes to identify the clinical endpoints where bezisterim had the greatest effect and within which patient subpopulations, and no single endpoint was designated as primary. ADDRESS-LC also evaluated a series of biomarkers, and these data are pending analysis and will be presented at a future medical meeting.
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