BioVie shares Phase 2 bezisterim data for Long COVID treatment

BioVie Inc. (NASDAQ: BIVI) presented results from its Phase 2 ADDRESS-LC trial evaluating bezisterim (NE3107) in Long COVID patients at the 151st Annual Meeting of the American Neurological Association, held Oct. 17–20, 2026, in San Diego.

The randomized, double-blind, placebo-controlled trial enrolled 203 patients who received bezisterim or placebo for 12 weeks. The study assessed 22 clinical outcome measures, with no single endpoint designated as primary. In the overall intent-to-treat population, bezisterim did not achieve statistical significance on any endpoint.

Statistically significant results were observed in pre-specified subgroups of patients with greater baseline symptom burden. Among the most fatigued patients at baseline, mean improvement in PROMIS Fatigue at Week 12 was 8.93 points with bezisterim compared with 5.30 points with placebo (p=0.02). Patients with high baseline post-exertional malaise showed statistically significant differences in objective global cognition, processing speed, and attention. Those with greater objective cognitive impairment at baseline also showed significant treatment differences in global cognition and three cognitive domains.

Approximately 78% of trial participants had more severe symptoms in at least one of these domains at baseline.

On safety, treatment-emergent adverse events were reported in 41.6% of bezisterim patients versus 55.9% in the placebo group. No serious adverse events were reported in the bezisterim group; one was reported in the placebo group.

"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 cognitive function among patients with greater baseline symptom burden," said Penelope Markham, BioVie's Senior Vice President and Program Lead for Long COVID. "We believe these findings provide an important foundation for the design of a confirmatory Phase 3 study."

The ADDRESS-LC study is funded by a $13.13 million grant through the Peer-Reviewed Medical Research Program. Biomarker data from the trial are pending analysis and will be presented at a future meeting.

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