BioVie Inc. (NASDAQ: BIVI) has received the final scientific approval from the U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO), to proceed with its Phase 2 clinical trial evaluating bezisterim for the treatment of neurological symptoms associated with long COVID. This approval triggers the release of an additional $12.6 million in grant funding from the U.S. Department of Defense (DOD). The FDA had previously reviewed and approved the study as Safe to Proceed in August 2024.
Phase 2 Trial Details
The planned Phase 2 study is designed as a randomized (1:1), placebo-controlled, multicenter trial involving approximately 200 patients. The trial will assess the safety, tolerability, and potential efficacy of a three-month treatment regimen with bezisterim in reducing neurocognitive symptoms linked to long COVID. The company anticipates the trial will commence by early 2025.
The Need for Long COVID Therapies
Long COVID is characterized by the persistence of COVID-19 symptoms for three months or longer. The Centers for Disease Control (CDC) reports that over 17 million adults in the United States have experienced long COVID. Common symptoms include cognitive dysfunction and fatigue, which can be debilitating. Currently, there are no proven effective therapies for this condition.
Bezisterim's Mechanism of Action
Chronic inflammation is a leading hypothesis explaining the persistence of long COVID symptoms. Specifically, individuals with "brain fog" often exhibit sustained systemic inflammation and blood-brain-barrier (BBB) dysfunction. Bezisterim is an orally bioavailable, BBB-permeable agent with both insulin-sensitizing and anti-inflammatory properties. It modulates inflammation by affecting NF-kB activation, offering a targeted approach to address the underlying causes of long COVID symptoms.
Department of Defense Support
The research is supported by the Assistant Secretary of Defense for Health Affairs and the Department of Defense through the Peer-Reviewed Medical Research Program (PRMRP). The initial planning phase was funded with $499,200, with the potential for an additional $12.6 million upon meeting specific milestones and initiating the clinical trial.
Bezisterim Beyond Long COVID
Bezisterim is also under investigation for Alzheimer’s disease (AD) and Parkinson’s disease (PD). BioVie has reported efficacy data from a Phase 3 trial in mild-to-moderate AD (NCT04669028). Additionally, Phase 2 trial results presented at the CTAD conference in December 2022 indicated improved cognition and biomarker levels in bezisterim-treated patients. A Phase 2 study in PD (NCT05083260) showed improvements in "morning on" symptoms and motor control when bezisterim was combined with levodopa.
