BioVie To Present Data from NE3107 Phase 2 Open-Label Trial at Society of Biological Psychiatry Annual Meeting
BioVie Inc. (NASDAQ: BIVI) announced that a data abstract from its Phase 2 open-label trial of NE3107 in degenerative dementias has been accepted for presentation at the 78th Annual Scientific Convention of the Society of Biological Psychiatry in San Diego from April 27-29, 2023. The study titled Effects of NE3107 on Depression and Multimodal Outcomes in a Phase 2, Open-Label Study in Patients with Cognitive Decline Due to Degenerative Dementias will be presented by Nily Osman, MD. NE3107 is designed to inhibit inflammatory activation linked to neurodegenerative disorders like Alzheimer's and Parkinson's diseases. The company is also conducting a pivotal Phase 3 study to evaluate NE3107 in Alzheimer's patients. Additionally, BIV201, a continuous infusion terlipressin, is being assessed in a Phase 2b study for refractory ascites due to liver cirrhosis.
- Data from Phase 2 trial of NE3107 accepted for presentation at major conference.
- Conducting a pivotal Phase 3 study for NE3107 in Alzheimer's patients.
- Previous Phase 2 results indicated improved cognition and biomarker levels in NE3107-treated patients.
- BIV201 has FDA Fast Track status for refractory ascites due to liver cirrhosis.
- None.
CARSON CITY, Nev., April 20, 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, today announced that a data abstract from its Phase 2 open label trial evaluating NE7107 in degenerative dementias has been accepted for presentation at the 78th Annual Scientific Convention of the Society of Biological Psychiatry, to be held in San Diego, CA April 27-29, 2023.
Details for the presentation are as follows:
Effects of NE3107 on Depression and Multimodal Outcomes in a Phase 2, Open-Label Study in Patients with Cognitive Decline Due to Degenerative Dementias
- Date/time: 4/28/23 @5:00-7:00pm PDT
- Presenter: Nily Osman, MD FRCP(C)
About BioVie
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 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/.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the Company’s strategy, plans and objectives, such as statements regarding the Company’s anticipated timeline for announcing results from the NE3107 Phase 3 potential pivotal trials. 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.
For Investor Relations Inquiries:
Contact:
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
FAQ
What is the purpose of the Phase 2 trial for NE3107?
When and where will the NE3107 study results be presented?
What are the implications of NE3107 for Alzheimer's disease?
What is BIV201 and its current status?
