Long COVID continues to impact millions worldwide, with no approved treatments currently available. The persistent neurological symptoms, often referred to as “brain fog,” can significantly impair daily life. However, a recent announcement offers a glimmer of hope: the FDA has authorized an Investigational New Drug application to evaluate bezisterim (NE3107) for treating these debilitating neurological symptoms.
This exciting development marks a critical step towards finding effective solutions for long COVID sufferers. BioVie Inc., the company behind bezisterim, announced the FDA’s authorization, paving the way for a phase 2 clinical trial.
The Promise of Bezisterim
The planned phase 2 trial will involve approximately 200 patients, randomized to assess the safety and tolerability of bezisterim over a 3-month treatment period. The study will also investigate the drug’s potential to alleviate neurocognitive symptoms associated with long COVID.
According to BioVie, bezisterim is an orally bioavailable insulin sensitizer with anti-inflammatory properties and a low risk of drug interactions. Preclinical studies suggest that bezisterim may reduce inflammation by modulating the activation of NFkB, a key player in the inflammatory cascade. It is believed that persistent viral spike proteins in long COVID patients trigger TLR-4 driven activation of NFkB, leading to the release of inflammatory cytokines. Bezisterim’s ability to modulate this pathway could offer significant relief from neuroinflammation, a potential driver of “brain fog.”
Understanding Long COVID and Its Neurological Impact
Long COVID is characterized by the persistence of COVID-19 symptoms for 3 months or more after the initial infection. These symptoms can include fatigue, loss of taste and smell, and the cognitive impairment known as “brain fog.” The underlying mechanisms of long COVID are still being investigated, but inflammation and blood-brain-barrier dysfunction are thought to play crucial roles, particularly in neurological manifestations.
Elevated levels of inflammatory proteins, such as CD48 and TNF, have been observed in long COVID patients. This persistent inflammation may contribute to the neurological symptoms experienced.
Current Research Landscape for Long COVID Treatments
While there are no currently approved treatments for long COVID, several promising avenues are being explored. Metformin, a common diabetes medication, has shown potential in reducing the risk of developing long COVID. Hyperbaric oxygen therapy has also demonstrated some efficacy in repairing brain tissue damaged by COVID-19.
Bezisterim: Beyond Long COVID
The potential of bezisterim extends beyond long COVID. It is also being investigated as a potential treatment for Alzheimer’s disease and Parkinson’s disease. Preliminary results from a phase 2 trial in Alzheimer’s patients have shown improvements in biomarker levels and cognition, suggesting the drug’s anti-inflammatory properties may have broader therapeutic applications.
Looking Ahead
The FDA’s authorization of the bezisterim trial brings hope to those struggling with the neurological consequences of long COVID. While further research is needed, the potential for a targeted therapy addressing the underlying inflammatory mechanisms of this debilitating condition is a significant advancement.
For personalized treatment plans and advice on managing long COVID symptoms, it’s essential to consult with a healthcare professional.
References
- BioVie. BioVie announces FDA authorization of investigational new drug application for phase 2 trial to evaluate bezisterim in long COVID. News Release. Released September 3, 2024. Accessed September 3, 2024. https://www.globenewswire.com/en/news-release/2024/09/03/2939596/0/en/BioVie-Announces-FDA-Authorization-of-Investigational-New-Drug-Application-for-Phase-2-Trial-to-Evaluate-Bezisterim-in-Long-COVID.html
- Gallagher A. Study: Metformin shows efficacy preventing development of long COVID. Pharmacy Times. Published June 20, 2023. Accessed September 3, 2024. https://www.pharmacytimes.com/view/study-metformin-shows-efficacy-preventing-development-of-long-covid
- Hunter E. Hyperbaric oxygen therapy may be the first, only clinically effective treatment for long COVID. Pharmacy Times. Published February 26, 2024. Accessed September 3, 2024. https://www.pharmacytimes.com/view/hyperbaric-oxygen-therapy-may-be-the-first-only-clinically-effective-treatment-for-long-covid
- National Center for Health Statistics. US Census Bureau, Household Pulse Survey, 2022–2024. Long COVID. Last Reviewed August 21, 2024. Generated September 3, 2024 from https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm.
