BioVie Inc (NASDAQ:BIVI, NASDAQ:BIVIW) announced that has completed the last on-treatment visit in its Phase 2 ADDRESS-LC clinical trial evaluating bezisterim in adults with Long COVID, with topline results targeted for release before the end of September 2026.
The Carson City, Nevada-based clinical-stage company is developing therapies for neurological and neurodegenerative diseases. The ADDRESS-LC study is evaluating whether bezisterim can improve neurological symptoms associated with Long COVID, including cognitive impairment and fatigue.
The randomized, 1:1 placebo-controlled, multicenter Phase 2 trial is designed as a proof-of-concept study assessing the efficacy, safety and tolerability of bezisterim. Participants receive either a 20-milligram oral capsule of the drug twice daily or a matching placebo.
With the final on-treatment visit completed, BioVie noted that the one-month virtual follow-up period is nearly finished. The company expects to report topline data from the study before the end of September.
The trial is fully funded through a grant from the U.S. Department of War, formerly the US Department of Defense.
ADDRESS-LC is evaluating several measures related to Long COVID symptoms. These include changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, quality of life and post-exertional malaise.
"With the last patient's treatment visit completed, and the one-month virtual follow-up nearly complete, we anticipate announcing topline results for ADDRESS-LC before the end of September 2026," BioVie CEO Cuong Do said
"The growing body of research surrounding Long COVID continues to reinforce the rationale for bezisterim's proposed mechanism, particularly its modulation of inflammatory pathways associated with symptoms relating to fatigue and 'brain fog.'"
Penelope Markham, BioVie's senior vice president of liver disease and Long COVID programs, added that the company was grateful to trial participants, investigators and site staff, as well as members of the Long COVID community who supported enrollment and participation.
BioVie noted that an estimated 17 million to 20 million US adults are living with Long COVID, with about 3.8 million experiencing significant limitations to their daily lives. The company cited research indicating that neurological and neuropsychiatric symptoms are among the more common and disabling manifestations of the condition, including fatigue, post-exertional malaise, sleep disturbances and persistent difficulties with thinking and memory.
The company also pointed to chronic innate inflammation and ongoing immune dysregulation as leading hypotheses being investigated to explain Long COVID symptoms. BioVie believes findings from Long COVID research support biological targets relevant to bezisterim.
There are currently no FDA-approved treatments specifically for Long COVID, according to the company. The upcoming ADDRESS-LC topline results are expected to provide an initial assessment of bezisterim's potential in the condition.
Shares of BioVie had gained nearly 14% on Monday afternoon.