Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 99

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 99
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 forms the basis for the Company’s
work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada,
Europe and South Korea.

Parkinson’s Disease

Parkinson’s disease (“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 Phase 2 study of bezisterim (NE3107) for the
treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off
state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design
objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for
adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications
of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

To extend this Phase 2 data in progressed patients,
the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset
PD. In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with
the study. The trial commenced in April 2025.

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Long COVID Program

In April 2024, the Company announced the grant