Investigational Long COVID Therapy Enrolls First Phase 2 Participant

Carson City, Nevada-based NevBiovie announced today it has enrolled its first participant for it phase 2 clinical trial, ADDRESS-LC, which will study its investigational therapy, bezisterim, and will evaluate its safety and efficacy on motor and non-motor symptoms in patients who have not been treated with carbidopa/levodopa. “This trial will explore whether targeting these mechanisms can help restore normal function and improve quality of life for individuals affected by the neurological symptoms of Long COVID, and we look forward to sharing our findings in the first half of 2026,” BioVie CEO Cuong Do, said in a statement.

This study, which is fully funded by a grant from the US Department of Defense (DOD), is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue.

The Molecule

Bezisterim is a small molecule that is orally bioavailable, blood-brain barrier-permeable, and not immunosuppressive—a favorable pharmacological profile for long-term use in chronic inflammatory CNS conditions. In addition, it is not immunosuppressive and has a low risk of drug-drug interactions. By binding to ERK and selectively modulating NFκB activation and TNF-α production.

“Bezisterim has demonstrated the ability to modulate key inflammatory pathways implicated in the chronic inflammation seen in long COVID, that also play a key role in neurodegenerative diseases of aging, like Parkinson’s and Alzheimer’s,” stated Do.

It is also being studied in ongoing phase 2 trials in Parkinson’s disease (SUNRISE-PD) and has completed phase 3 evaluation in Alzheimer’s disease.

Long COVID’s Burden

This condition can include a number of symptoms such as fatigue, brain fog, and cognitive impairment and can impact the quality of life for suffers. It is believed to affect approximately 20 million adults in the US, and millions more worldwide.^2,3

Currently, there are no FDA-approved therapies for Long COVID. Thus far, treatment has focused on optimizing function and quality of life through symptom management approaches and holistic support.

“By reducing neuroinflammation and addressing potential metabolic dysfunction, our hope is that bezisterim may have the potential to help patients with long COVID,” Do said.

Individuals who have been diagnosed with Long COVID and have neurocognitive dysfunction and self-reported fatigue may meet qualification criteria and can visit this site to learn more.

Reference
1. BioVie Enrolls First Patient in ADDRESS-LC Clinical Trial Assessing Novel Anti-Inflammatory Candidate Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID
2. Ford ND, Agedew A, Dalton AF, Singleton J, Perrine CG, Saydah S. Notes from the Field: Long COVID Prevalence Among Adults — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:135–136
3.National Center for Health Statistics. U.S. Census Bureau, Household Pulse Survey, 2022–2024. Long COVID. Generated interactively: April 24, 2025 from https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm