Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 196

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 196
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 with tumor necrosis factor (“TNF”) signaling and other
relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. Bezisterim (NE3107) does not interfere with their
homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of
AD and PD.

Parkinson’s Disease

To extend the Phase 2 data in progressed patients
from the previous Phase 2 study that completed in December 2022, the Company 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.

The previous Phase 2 study of bezisterim (NE3107)
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 (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.

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