BioVie Awarded up to $13.1 Million in Funding from U.S. Department of Defense to Evaluate Bezisterim (NE3107) for the Treatment of Long COVID

Increasing evidence supports a role for viral persistence, chronic inflammation and immune and metabolic dysregulation in driving long COVID

Bezisterim, an anti-inflammatory and insulin-sensitizer that permeates the blood brain barrier, could represent a novel oral treatment targeting an underlying cause of long COVID symptoms

CARSON CITY, Nev., April 29, 2024 (GLOBE NEWSWIRE) --  BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (DOD), awarded through the Peer Reviewed Medical Research Program (PRMRP) of the Congressionally Directed Medical Research Programs (CDMRP). The award can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess the Company’s anti-inflammatory and insulin sensitizer candidate, bezisterim (NE3107), for the treatment of neurological symptoms that are associated with long COVID. The Company anticipates the trial to commence by early 2025.

Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously had long COVID.¹ Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating. The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars.² To date there are no therapies proven effective for treatment.

Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.³   Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.⁵ Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting an underlying cause of long COVID symptoms.