Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 6

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 6
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The Phase 2 study of bezisterim for the treatment
of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
study in PD participants treated with carbidopa/levodopa and bezisterim. Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim 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
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.

B. Long COVID Program

About Long COVID

Long COVID is a condition in which symptoms of
COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more.
Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular
and respiratory problems, muscle weakness, and neurologic issues have also been documented.

Approximately 20 million individuals in the U.S.
currently or previously have long COVID, with millions more impacted worldwide.1,2 Studies estimate that approximately 10-30% of individuals
who contract COVID-19 experience lingering symptoms for months or even years, with fatigue, brain fog, and cognitive impairment significantly
impacting daily functioning and quality of life. Despite the growing recognition of long COVID as a serious condition, treatment options
remain limited, and many patients struggle to find effective relief for their symptoms. The loss in quality of life and earnings and increased
medical costs has an enormous economic impact estimated to be $3.7 trillion. To date there are no non-pharmacological or pharmacological
therapies proven effective for treatment of long COVID

In April 2024, the Company was awarded a clinical trial grant of $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 Command, Office of Human Research Oversight
(“OH