Company: BIVIW
Filing Date: 2025-10-06
Form Type: POS AM
Source: 0001520138-25-000294
Chunk: 6

Company: BIOVIE INC.
Filing Date: 2025-10-06
Form: POS AM
Chunk 6
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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. 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