Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 78

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 78
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dose levodopa. Although levodopa provides symptomatic benefit, it does not slow PD progression.   

 21 

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.

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
Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for
the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”)
application for bezisterim (NE3107) allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating
neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence in May 2025.

Liver Disease Program

In liver disease, our investigational drug