Neurodegeneration

BioVie is developing first-in-class molecules for the treatment of neurological and neuro-degenerative disorders

BioVie's leading clinical candidate, NE3107, is an orally administered small molecule, anti-inflammatory, insulin-sensitizing agent with a novel mechanism of action is entering a potentially pivotal phase 3 clinical trial for the treatment of mild to moderate Alzheimer’s disease. Clinical trials in Parkinson’s disease, multiple myeloma and prostate cancer are also planned to begin in 2021.

There is substantial scientific literature describing the role of neuroinflammation in neurodegenerative disease. Inflammatory signals mediated by Extracellular signal Regulated Kinases (ERK 1 and 2) and Nuclear Factor Kappa B (NFκB) are the major drivers of neurodegenerative disease. The drug binds to ERK and specifically inhibits ERK and NFκB in inflammatory signaling pathways without inhibiting ERK and NFκB homeostatic functions. NE3107 exclusivity is protected by a combination of composition of matter and method patents, which are entirely owned worldwide by Biovie. The Company’s intellectual property is protected up to 2034. Successor compounds comprising new compositions of matter are in development.
NE3107’s mechanism acts on the fundamental inflammatory signaling pathways that are the root cause of Alzheimer’s and other neurodegenerative diseases. NE3107’s mechanism of action makes it a disease modifying agent.

NE3107 is orally administered, and rapidly absorbed into the bloodstream where it freely penetrates the blood-brain barrier. NE3107 has a favorable safety profile in animals and in phase 1 and phase 2 human studies conducted to date.

Clinical applications span a wide range of diseases

Alzheimer's Disease

  • Reducing inflammation and insulin resistance in Alzheimer's

Parkinson's Disease

  • Reducing inflammation, insulin resistance in low dopamine environments
  • TNF reduction reduces levodopa-induced dyskinesia

Multiple Myeloma

  • MM cells secrete cytokines (eg, TNFα) and chemokines (eg, MCP-1) that stimulate inflammation
  • Targets NFkB, ERK, TNF, MCP-1, and IL-6 implicated in MM

Prostate Cancer

  • NFkB/ERK drives IL-23 and IL-6 production, leading to castrate-resistant prostate cancer
  • Targets ERK-dependent IL-23 and IL-6 production and may inhibit formation of CRPC

Intellectual Property

NE3107 exclusivity is protected by a combination of composition of matter and method patents, which are entirely owned worldwide by NeurMedix. The Company’s intellectual property is protected up to 2034.

Publications

A link to NE3107 publications will be coming soon.

Forward Looking Statements
This website contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties, and assumptions that could cause BioVie’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements.
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