Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 36

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 1
Chunk 36
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.g., insulin signaling and neuron growth and survival). Both
inflammation and insulin resistance are drivers of AD and PD.

Chronic neuroinflammation, insulin resistance, and
oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic
lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory,
insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work
testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe
and South Korea.

Parkinson’s Disease 

Parkinson’s disease (“PD”) is driven
in large 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.   

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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