CARSON CITY, Nev., Sept. 07, 2023 (GLOBE NEWSWIRE) — BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, is hosting today a virtual KOL event titled NE3107―Putting Data in Context, ahead of the upcoming Phase 3 results in Alzheimer’s Disease. The event will take place today at 2:30pm ET. To register, click here.
The event will focus on BioVie’s lead product candidate, NE3107, currently in a potentially pivotal Phase 3 study in patients with mild to moderate Alzheimer’s disease with expected topline data readout in the fourth quarter of 2023. The company’s leadership team and Key Opinion Leader (KOL) Steven E. Arnold, MD (Harvard Medical School; Massachusetts General Hospital) will discuss the totality of NE3107 data generated to date including:
- The role of neuroinflammation and insulin resistance in Alzheimer’s Disease pathology.
- The potential for NE3107 to have an active epigenetic effect associated with improvements in inflammation, insulin signaling, and other critical biological processes in a manner that is significantly correlated to improvements in cognition.
- An overview of results observed in the NE3107 Phase 2 exploratory biomarker study.
A live question and answer session will follow the formal presentations.
About Steven E. Arnold, MD
After receiving his MD from Boston University, Dr. Arnold completed residency training in Psychiatry at the New York State Psychiatric Institute / Columbia Presbyterian Medical Center in New York, residency training in Neurology and fellowship training in Behavioral Neurology at the University of Iowa Hospitals and Clinics in Iowa City. Dr. Arnold is board certified in both neurology and psychiatry. At the Massachusetts General Hospital, Dr. Arnold leads the Alzheimer’s Clinical and Translational Research Unit, conducting early phase clinical trial and biomarker research. He is also Managing Director of the Interdisciplinary Brain Center, a new collaboration of the Departments of Neurology, Psychiatry and Radiology. Its mission is to facilitate the discovery, development, and implementation of promising therapeutics and associated diagnostics for individuals with complex brain disorders affecting cognition, behavior and emotion. Dr. Arnold has conducted longstanding research on neurodegenerative disease pathology, molecular biomarkers and therapeutics for cognitive decline and psychiatric syndromes in late life and has led broad clinical and translational research programs. He has authored over 250 scientific articles, reviews and chapters. Current scientific interests include biomarkers in brain aging and dementias, metabolic factors driving dementia, and protective factors that account for cognitive resilience, all with the goal of accelerating therapeutics discovery and development.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. 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 probable Alzheimer’s disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) has completed, and data presented at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. 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. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit http://www.bioviepharma.com/.
This press release contains forward-looking statements, including statements regarding the Company’s strategy, plans and objectives. Forward-looking statements may generally be identified by words such as “expect,” “look forward to,” “anticipate” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “project” or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due risks associated with conducting and completing clinical trials, including our reliance on third parties to conduct our clinical trials, to successfully defend potential future litigation, our ability to raise capital when needed on reasonable terms, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company’s control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
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