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SANTA MONICA, Calif., Oct. 13, 2021 (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, today announced that it will host a key opinion leader (KOL) webinar on neuroinflammation and insulin resistance and new treatment approaches for Alzheimer’s Disease on Tuesday, October 26, 2021 at 1:30 pm Eastern Time.
The webinar will feature presentations by KOLs Jefferson Kinney, Ph.D., University of Nevada, Las Vegas, who will discuss the basis of inflammation as a central mechanism in Alzheimer’s disease, and Karl Herrup, Ph.D., University of Pittsburgh School of Medicine, who will discuss the importance of age-related hyperinsulinemia and brain insulin resistance in neurodegeneration.
BioVie's management team will also discuss NE3107 for the treatment of Alzheimer's disease. NE3107’s mechanism acts on both the fundamental inflammatory signaling pathways and the consequent insulin resistance that are the root causes of Alzheimer’s and other neurodegenerative diseases. BioVie recently announced that the Company has enrolled the first patient into the NM101 Phase III clinical study testing NE3107 for the treatment of Alzheimer’s Disease (AD). The NM101 study is a potentially pivotal Phase 3, randomized, double-blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate AD.
A live Q&A session will follow the formal presentations. To register for the webinar, please click here.
Jefferson Kinney, Ph.D., is the Founding Chair of the Department of Brain Health and holds the Reg Grundy and Joy Chambers-Grundy Chair for Brain Health in the Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas (UNLV). He is the Director of the Cellular and Molecular Brain Research Laboratory and the Translational Biomarker Discovery Laboratory. Dr. Kinney earned his Ph.D. at Colorado State University and was awarded an Intramural Research Training Fellowship at the National Institute of Mental Health investigating the biology and behavior of transgenic mouse models of Alzheimer’s disease. He was then selected as the Helen Dorris Fellow in the Department of Neuropharmacology at The Scripps Research Institute where he conducted research on molecular mechanisms in neurological disorders. He joined the UNLV faculty in 2007. Dr. Kinney’s primary research focus is on investigating cellular and molecular mechanisms underlying Alzheimer’s decease with particular emphasis on neuronal-glial interactions. Dr. Kinney’s work is directed at understanding how specific immune signaling pathways are altered in pre-clinical Alzheimer laboratory models, as well as understanding the mechanisms underlying how Diabetes confers increased risk for developing Alzheimer’s disease. More recently, Dr. Kinney has expanded these investigations into biomarker discovery research projects in clinical populations. Dr. Kinney’s translational research approach is aimed at identifying disease mechanisms that may serve as new therapeutic targets as well as discovering novel biomarkers that can be used in detection, diagnosis, and evaluation of treatment efficacy of Alzheimer’s disease. Dr. Kinney’s research provides a foundation for understanding the risk of developing AD and the utility of personalized treatment approaches to preserve brain health. Dr. Kinney received the Top Tier Scientist Award, among the most prestigious honors bestowed by UNLV.
Karl Herrup, Ph.D., received his Bachelor’s degree from Brandeis University in Waltham, MA and his Ph.D. in Neuroscience from Stanford University. After two postdoctoral fellowships – in Neurogenetics at Children’s Hospital/Harvard Medical School, and in Neuropharmacology at the Biozentrum in Basel Switzerland – he joined the faculty of the Human Genetics Department of Yale Medical School as an Assistant, then Associate, Professor. He became Director of the Division of Developmental Neurobiology at the E. K. Shriver Center in Waltham, MA before moving to the Departments of Neurosciences and Neurology at Case Western Reserve University Medical School and University Hospitals of Cleveland. While in Cleveland, he directed the University Alzheimer’s Center for six years. In 2006 he moved to the Piscataway/New Brunswick campus of Rutgers University to become Professor and Chair of the Department of Cell Biology and Neuroscience. In July 2012, he moved to Hong Kong to become the Head of Life Science at The Hong Kong University of Science and Technology. He returned to the United States in March 2019 to become a Professor of Neurobiology at the University of Pittsburgh. His laboratory research is focused on the biology of nerve cell death and the paradoxical role that failed cell cycle regulation plays in the process. His work includes a strong translational interest that directs his studies towards a few select human neurodegenerative diseases including Alzheimer’s, a very common late-life dementia, and ataxia-telangiectasia, a very rare multisystem disorder of childhood.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing transformative therapies to overcome unmet medical needs in chronic debilitating conditions. 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 2 study for the treatment of refractory ascites with top-line results expected in early 2022. The Company is also planning a pivotal Phase 3 study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI) in 2022. 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. In neurodegenerative disease, BioVie acquired the assets of NeurMedix Inc., including NE3107 that inhibits inflammatory activation of ERK and NFB (e.g. TNF transcription) 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 subjects who have mild to moderate Alzheimer's disease (NCT04669028). An estimated six million Americans suffer from Alzheimer’s. BioVie has initiated this study and is targeting primary completion in late 2022. A Phase 2 study of NE3107 in Parkinson’s disease is planned to start later this year, and related compounds have additional potential to treat certain cancers. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea. For more information, visit http://www.biovieinc.com/.
This press release contains forward-looking statements, which may 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 to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our clinical studies and to obtain approval for our product candidates, to successfully defend potential future litigation, 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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