NE3107 at the 2022 Clinical Trials on Alzheimer’s Disease Annual Meeting
Results from BioVie’s investigator-sponsored exploratory biomarker and imaging trial of NE3107 for the treatment of Alzheimer’s Disease (AD) were presented at this year’s Clinical Trials on Alzheimer’s Disease (CTAD) Annual Meeting, in San Francisco, CA and virtually.
The 15th annual CTAD meeting featured three abstracts highlighting clinical outcomes and neuroimaging data from the potentially pivotal Phase 2 study.
CTAD Poster 034
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BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating conditions. In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of Alzheimer’s and Parkinson’s diseases. The Company is conducting a potentially pivotal Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer’s disease (NCT04669028) and is targeting primary completion in mid-2023. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) is fully enrolled and expects to have topline data readout in December 2022. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis with top-line results anticipated in mid-2023. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in about 40 countries for related complications of advanced liver cirrhosis but is not available in the US or Japan.