BioVie Inc. has presented promising Phase 2 results for bezisterim (NE3107), an experimental drug for long COVID, at the 151st Annual Meeting of the American Neurological Association in San Diego. According to GlobeNewswire, data from the ADDRESS-LC trial showed statistically significant improvements versus placebo across fatigue, post-exertional malaise, and objective cognitive measures in patients who entered the study with higher baseline symptom burden.
The randomized, double-blind, placebo-controlled trial enrolled 203 patients who received bezisterim or placebo for 12 weeks. Researchers measured 22 different clinical outcomes — without designating a single primary endpoint — to identify where the drug had its greatest effect and in which patient subgroups. The study's abstract was published in Annals of Neurology in conjunction with the October 17–20, 2026 meeting.
Psychiatric Times reported that among the most fatigued half of patients at baseline, mean improvement in PROMIS Fatigue scores at week 12 was 8.93 points with bezisterim compared with 5.30 points with placebo, a statistically significant difference. In patients with high baseline post-exertional malaise, the drug also produced significant gains in objective global cognition, processing speed, and attention measures.
Bezisterim is an investigational oral drug that crosses the blood-brain barrier and modulates neuroinflammation pathways including ERK, NFκB, and TNFα, improving insulin sensitivity without suppressing the immune system. "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," said Penelope Markham, BioVie's senior vice president and program lead for long COVID.
Biomarker data from the trial are still being analyzed and will be presented at a future medical meeting. BioVie says the findings will guide the design of a larger confirmatory Phase 3 study — welcome news for the millions still waiting for an approved long COVID treatment.