BioVie Inc.

BioVie Inc. is a clinical-stage company focused on developing new drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease. The company's primary neurodegenerative disease program centers on NE3107, also known as bezisterim. BioVie acquired the biopharmaceutical assets related to bezisterim from NeurMedix, Inc. in June 2021. Bezisterim is an investigational, orally administered small molecule designed to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades through a novel mechanism of action. Bezisterim is being developed based on the scientific understanding that inflammation and insulin resistance may contribute to Alzheimer's disease (AD) and Parkinson's disease (PD). If approved by the U.S. Food and Drug Administration (FDA), bezisterim could offer a new medical approach for treating these conditions, which affect an estimated 6 million Americans with AD, 1 million Americans with PD, and approximately 20 million adults in the US with Long COVID. As a drug candidate, bezisterim is an orally bioavailable, Blood Brain Barrier (BBB)-permeable, and anti-inflammatory agent that acts as an insulin-sensitizer. It is not immunosuppressive and carries a low risk of drug-drug interaction. Bezisterim works by inhibiting the activation of inflammatory extracellular single regulated kinase (ERK) and nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB), including interactions with tumor necrosis factor (TNF) signaling and other inflammatory pathways that contribute to neuroinflammation and insulin resistance. By selectively modulating NFκB activation and TNF-α production without interfering with their homeostatic functions, BioVie believes bezisterim may offer clinical improvements in conditions such as PD, AD, and long COVID. BioVie has conducted and reported efficacy data from its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study (NCT04669028) evaluating bezisterim in patients with mild-to-moderate AD.