Company: BIVIW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001520138-25-000343
Chunk: 7

Company: BIOVIE INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 1
Chunk 7
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-α production and not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical
improvements in several disease indications, including PD, AD and long COVID.

Parkinson’s Disease 

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.

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.

Long COVID Program

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.

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