Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 5

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 5
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 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.

<div align='center'>2</div>

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 levodopa
provides symptomatic benefit, it does not slow PD progression.

The Company designed a new Phase 2b study of bezisterim
as a potential first line therapy to treat patients with new onset PD. This trial will be evaluating the safety and efficacy of bezisterim
on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa. The PD Phase 2b study , multicenter,
randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial screening phase
to the safety follow up. In July 2024, the Company submitted the new protocol and received a response from the FDA permitting the Company
to proceed with the study. The trial commenced in April 2025.