The economic impact of long COVID is substantial, with estimates suggesting a cost of approximately $3.7 trillion due to loss of quality of life and increased medical expenses.

Bezisterim is an anti-inflammatory insulin sensitizer that modulates inflammation through the activation of NFkB, with its potential efficacy based on evidence suggesting that inflammation is a key driver of long COVID symptoms.

Currently, there are no approved treatments for long COVID, highlighting the critical need for effective therapies.

BioVie Inc. has received FDA authorization for its investigational new drug application to evaluate bezisterim for treating neurological symptoms associated with long COVID.

Cuong Do, BioVie's President and CEO, emphasized the significance of this milestone in addressing the urgent needs of patients suffering from long COVID.

The drug bezisterim is designed to target neurocognitive symptoms related to long COVID, which affects approximately 5.5% of U.S. adults, translating to around 3.6 million individuals who have modified their daily activities due to the condition.

Despite facing financial challenges, including an operating loss of $38.37 million in the last twelve months, BioVie holds more cash than debt, providing a buffer for ongoing clinical trials.

The Department of Defense grant will support the clinical trial, starting with a planning phase funded at $499,200, with additional funding contingent on meeting milestones.

BioVie is on track to receive an additional $12.6 million from the U.S. Department of Defense to initiate a Phase 2 clinical trial ahead of schedule.

The planned Phase 2 trial will involve approximately 200 patients and will evaluate bezisterim's safety, tolerability, and efficacy in reducing neurocognitive symptoms over a three-month period.

The DOD's support emphasizes the urgent need for effective treatments for long COVID, although the views expressed are those of BioVie and not necessarily the DOD.

In addition to long COVID, bezisterim is also being studied for its potential to treat Alzheimer’s and Parkinson’s diseases.