BioVie Inc (NASDAQ:BIVI), a clinical-stage company focused on innovative drug therapies, announced today the approval of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (DOD) to evaluate Bezisterim (NE3107) for treating neurological symptoms associated with long COVID.
Long COVID is characterized by prolonged symptoms following COVID-19 infection.
The trial, expected to commence by early 2025, will assess the safety and efficacy of Bezisterim in reducing neurological symptoms in approximately 200 patients over a three-month period.
Bezisterim, an anti-inflammatory and insulin sensitizer that crosses the blood-brain barrier, targets the underlying mechanisms believed to drive long COVID symptoms, including chronic inflammation and metabolic dysregulation.
Symptoms of Long COVID could stem from both peripheral and neuroinflammation, attributed to the sustained presence of SARS-CoV-2 RNA and spike protein.
Cuong Do, BioVie’s CEO told investors: “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 leads a Long COVID clinical trials program at the University of California, San Francisco, emphasized the alignment of Bezisterim’s mechanism of action with emerging evidence for the underlying pathophysiology of Long COVID, expressing excitement about the trial's funding approval.
“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,” Peluso said.
The clinical trial is supported by the Assistant Secretary of Defense for Health Affairs, with an initial funding of $499,200 for the planning phase and an option to execute the $12.6 million clinical trial thereafter. The trial aims to address the unmet medical need in long COVID treatment and provide valuable insights into the therapeutic potential of Bezisterim.
Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin sensitizer with anti-inflammatory properties. Developed by BioVie, Bezisterim targets the underlying mechanisms believed to drive long COVID symptoms, offering potential therapeutic benefits for patients suffering from neurological symptoms associated with the condition.