Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 7

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 7
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 or (“bezisterim”). Bezisterim, the approved generic name for NE3107 is an investigational,
novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory
cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play
fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”),
and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach
to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD , 1 million Americans suffering
from PD and Long COVID affects approximately 20 million adults in the US, and millions more worldwide.

In neurodegenerative disease, the Company’s
drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier (“BBB”)-permeable, insulin-sensitizer that is also
anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim inhibits activation
of inflammatory action 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 relevant
inflammatory pathways) that lead to neuroinflammation and insulin resistance. By binding to ERK and selectively modulating NFκB
activation and TNF-α production and not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical
improvements in several disease indications, including PD, AD and long COVID.

BioVie has conducted and reported efficacy data
on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who
have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients
experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference
in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed,
and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and