BioVie Gets FDA Approval for Phase 2 Long COVID Drug Trial

BioVie Inc. (NASDAQ: BIVI), a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders as well as advanced liver disease, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This approval allows the company to investigate the use of bezisterim for managing neurological symptoms linked to long COVID. Achieving this milestone ahead of schedule, BioVie is set to receive an additional $12.6 million in funding from the U.S. Department of Defense (DOD) to initiate a Phase 2 clinical trial.

“We are thrilled with the FDA’s authorization of our IND application for bezisterim, enabling us to explore a new anti-inflammatory treatment approach for the challenging neurocognitive symptoms of long COVID,” stated Cuong Do, President and CEO of BioVie. “Emerging evidence suggests that inflammation is a central factor in long COVID, and we believe bezisterim shows potential in addressing these underlying mechanisms. This approval is a critical step toward understanding how bezisterim can help patients suffering from this debilitating condition.”

The upcoming Phase 2 trial is designed as a randomized, placebo-controlled, multicenter study involving approximately 200 participants. The primary aim is to assess the safety and tolerability of bezisterim over a three-month treatment period, along with its ability to alleviate neurocognitive symptoms associated with long COVID.

Long COVID is characterized by the persistence of COVID-19 symptoms for three months or longer. Recently, the Centers for Disease Control and Prevention (CDC) reported that around 5.5% of U.S. adults currently have long COVID, with approximately 3.6 million people having significantly modified their daily activities due to the illness. Symptoms often include cognitive dysfunction and fatigue, which can be debilitating. To date, no effective therapies have been identified for long COVID. Chronic inflammation is one of the main hypotheses explaining the persistence of symptoms, particularly in those experiencing “brain fog,” where ongoing systemic inflammation and blood-brain barrier dysfunction are key features. Bezisterim, which can penetrate the blood-brain barrier and modulate inflammation by activating NF-kB, represents a novel oral treatment targeting a suspected root cause of long COVID symptoms.

The work is endorsed by the Assistant Secretary of Defense for Health Affairs and supported by a grant amounting to $499,200 for the planning phase. Upon meeting specific milestones, BioVie has the option to receive an additional $12.6 million from the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113 to launch the clinical trial.

Long COVID symptoms can include lingering loss of smell and taste, hearing loss, extreme fatigue, and cognitive issues, among others. A CDC report indicated that more than 17 million U.S. adults have experienced long COVID, with 18.3% having had it at some point. The economic impact, including loss of quality of life and increased medical costs, is estimated at $3.7 trillion.

Bezisterim, an orally bioavailable drug that crosses the blood-brain barrier, is an anti-inflammatory agent that also acts as an insulin sensitizer without suppressing the immune system. It is being studied not only for long COVID but also for Alzheimer’s and Parkinson’s diseases. Data from a Phase 3 study on Alzheimer’s patients revealed improvements in cognition and biomarkers, while another Phase 2 study on Parkinson’s patients showed significant improvements in symptoms and motor control.

BioVie’s innovative approach to drug development includes bezisterim, which inhibits inflammatory activation linked to neuroinflammation and insulin resistance, and BIV201 for advanced liver disease. The latter is being evaluated for the treatment of ascites due to chronic liver cirrhosis, with the active agent approved in about 40 countries for related complications.

This latest FDA authorization marks a significant step forward in BioVie’s mission to develop effective treatments for debilitating conditions like long COVID.