Additionally, the Company announced approval of the non-proprietary name “bezisterim” for NE3107
CARSON CITY, Nev., April 18, 2024 (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 an oral presentation and poster presentation will be shared at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit to be held in Boston, Massachusetts April 23-25.
Additionally, the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “bezisterim” as the non-proprietary (generic) name for NE3107, an orally active partial NF-κB inhibitor product candidate being studied in Parkinson’s Disease and Alzheimer’s Disease.
The oral and poster presentations 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit will provide additional details on how bezisterim appears to have an impact on DNA methylation on 5 different “clocks” measuring biological age and that the extent of DNA methylation is correlated to a series of clinical measures.
The oral presentation titled “Clinical Outcomes and Biomarker Findings from a Randomized, Placebo-Controlled Trial of NE3107 in Subjects with Mild to Moderate Probably Alzheimer’s Disease” will be presented by Christopher L. Reading, BioVie’s Senior Vice President, Alzheimer’s Disease Program, on Wednesday, April 24 at 2:30 p.m. EDT. The poster with the same title will be presented at 6:45 p.m. on the same day.
Details of the presented data and conclusions will be announced once the presentations are made public at the conference.
About BioVie Inc.
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 bezisterim 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 conducted and reported efficacy data on its randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild to moderate Alzheimer’s disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of bezisterim 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 bezisterim 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 U.S Food and Drug Administration (“FDA”) Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. 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, 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 pre-clinical or clinical studies and to obtain approval for our product candidates, our ability 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.
For Investor Relations Inquiries:
Bruce Mackle
Managing Director, LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
For Media Relations Inquiries:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com
