Company: BIVIW
Filing Date: 2025-02-11
Form Type: 10-Q
Source: 0001520138-25-000056
Chunk: 2

Company: BIOVIE INC.
Filing Date: 2025-02-11
Form: 10-Q
Item: Part I, Item 2
Chunk 2
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 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.  

 22 

Table of Contents 

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 is anticipated to commence during the first calendar quarter of 2025.

Long COVID Program

In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed
Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development