BioVie Awarded up to $13.1 Million in Funding from U.S. Department of Defense to Evaluate Bezisterim (NE3107) for the Treatment of Long COVID - Seite 2

“The investigation of bezisterim in long COVID exemplifies the broad potential of therapies targeting inflammation and insulin sensitivity. This approach holds promise for a range of conditions where neuroinflammation is a key player, offering an avenue for advancements in care that are yet to be realized,” said Cuong Do, BioVie’s President & CEO. “Long COVID symptoms appear to be driven by peripheral and neuroinflammation resulting from persistence of SARS-CoV-2 RNA and spike protein. We believe the accumulating evidence behind this hypothesis supports the investigation of bezisterim to treat symptoms of long COVID and are pleased that this Department of Defense grant will enable further exploration of this molecule’s broader potential.”

Dr. Michael Peluso, who co-leads one of the first studies to examine the long-term effects of COVID and leads a Long COVID clinical trials program at the University of California, San Francisco stated “I am excited to see the trial with bezisterim receive funding given that recent advances in our understanding of the potential mechanism of action of bezisterim align with emerging evidence for the underlying pathophysiology of Long COVID”.

The Preliminary plans for the Phase 2b, randomized (1:1), placebo-controlled, multicenter trial are to evaluate the safety and tolerability of 3 months of treatment with bezisterim, along with its ability to reduce the neurological symptoms that are associated with long COVID, in approximately 200 patients.   

Terms of the Award
This project is supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with an option to execute the $12,6 million clinical trial after the planning phase has concluded, through the Peer Reviewed Medical Research Program under Award Number (HT9425-24-1-0300).

About Long COVID
Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, hearing loss, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously have long COVID.¹ The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be $3.7 trillion.² To date there are no non-pharmacological or pharmacological therapies proven effective for treatment of long COVID.