Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 81

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 81
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 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 related neurological
disorders in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful
improvement in motor control in patients treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone,
and no drug-related adverse events.

In long COVID, bezisterim has the potential to
reduce neurological symptoms including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to
trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg).

A. Parkinson’s Disease (NCT05083260)

Parkinson’s disease (PD) is a progressive
neurodegenerative disease most often characterized by tremors, muscle rigidity, slowness of movement, postural instability, and difficulties
with speech. Compelling evidence implicates inflammation and insulin resistance in the initiation and progression of the disease –
likely both due to their respective roles in dopamine dysfunction in the brain and neurodegeneration. Current therapeutic approaches provide
only symptomatic relief, but do not modify disease progression.

PD is driven in large part by neuroinflammation
and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of
levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa
effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled
movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levod