BioVie Announces Positive Results for Bezisterim in Long COVID Trial
News related to:BioVie Inc · 3 min read
BioVie Inc, a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, announced positive results from its Phase 2 ADDRESS-LC trial evaluating bezisterim, an oral drug that crosses the blood-brain barrier and is believed to reduce inflammation and improve insulin sensitivity. The trial, which enrolled 203 patients, aimed to assess whether bezisterim could improve key neurological symptoms associated with Long COVID, including fatigue, brain fog, cognitive impairment, and post-exertional malaise.
According to the topline results, bezisterim showed statistically significant benefits in pre-specified subgroups of patients with high baseline fatigue, cognitive impairment, and/or post-exertional malaise. Specifically, the drug demonstrated a consistent advantage over placebo on 21 out of 22 individual endpoints in the overall study population. The findings are particularly encouraging as they suggest that bezisterim may help improve symptoms in patients with high symptom burden, which represents approximately 80% of the trial participants.
The ADDRESS-LC trial was a multicenter, randomized, double-blinded, placebo-controlled exploratory study. Patients were grouped into distinct symptom-severity segments based on baseline characteristics that were pre-specified in the Statistical Analysis Plan submitted to the FDA prior to unblinding. The study explored 22 different measures to assess clinical outcomes and a series of different biomarkers. The results indicate that bezisterim may help improve symptoms of fatigue, post-exertional malaise, and cognitive impairments in patients with high symptom burden.
Dr. Michael Peluso, an Associate Professor of Medicine at the University of California, San Francisco, expressed excitement about the findings.
Ezra Spier, a Long COVID patient advocate and ADDRESS-LC Patient Advisor, echoed Peluso's sentiments.
The ADDRESS-LC trial was designed to identify the clinical endpoints where bezisterim may have the greatest effect and within which patient subgroups. The study evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of study success. Endpoints included assessing changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, quality of life, and post-exertional malaise.
Cuong Do, BioVie's President and CEO, commented on the significance of the results. "The results suggest that bezisterim may help improve symptoms of fatigue, post-exertional malaise, and cognitive impairments in patients with high symptom burden, which represents approximately 80% of patients who entered the trial. To our knowledge, this is the first time a drug candidate has shown the ability to help patients improve across these persistent Long COVID symptoms. Thus, bezisterim may have the potential to become the first therapy for the neurological symptoms of Long COVID, if confirmed in our future Phase 3 trial."
The safety and tolerability profile of bezisterim was similar to placebo. Overall, 41.6% of bezisterim patients experienced at least one treatment-emergent adverse event compared to 55.9% for placebo. The most frequently reported drug-related adverse event was headache, experienced by 4% of bezisterim-treated patients, compared to 4.9% for placebo. No serious adverse events were reported in the bezisterim arm.
The ADDRESS-LC trial was funded by a grant from the U.S. Department of War and was designed to identify efficacy signals, measure treatment effect magnitude, and identify patient subgroups most likely to benefit, to inform the design of future Phase 3 trials. The study evaluated whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long COVID.
BioVie management will host a conference call at 8:30 a.m. EDT today to discuss the findings and results. The call can be registered for at lifescievents.com/event/bkvp81.
As of September 15, 2026, an estimated 17 to 20 million U.S. adults are living with Long COVID and currently have no FDA-approved treatment options. The results of the ADDRESS-LC trial could potentially offer a significant breakthrough for patients suffering from this condition.