BioVie Announces Data Abstracts from NE3107 Phase 2 Trials Accepted for Presentation at AAN 2023

Rhea-AI Summary

BioVie, a clinical-stage company focused on innovative drug therapies for neurological disorders, announced data from its Phase 2 trials of NE3107 for degenerative dementias and Parkinson’s Disease. These abstracts will be presented at the 2023 American Academy of Neurology Annual Meeting, taking place April 22-27, 2023. Notable presentations include:

• Multi-Modal Correlation Analyses: April 25, 8:00-9:00 am ET
• Clinical Outcomes Study: April 25, 11:45 am-12:45 pm ET
• Safety and Efficacy Study: April 23, 8:00-9:00 am ET

BioVie is also advancing its Phase 3 study of NE3107 in Alzheimer’s patients and conducting a Phase 2b study for its liver disease treatment, BIV201. The latter has received FDA Fast Track designation.

Positive

• Phase 2 trials of NE3107 show promising data for degenerative dementias and Parkinson's disease.
• Presentation of significant trial results at the 2023 AAN Annual Meeting could enhance visibility and interest.
• BIV201 has received FDA Fast Track status, indicating potential for expedited review.

Negative

• None.

CARSON CITY, Nev., April 17, 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 data abstracts from its Phase 2 trials evaluating NE7107 in degenerative dementias and Parkinson’s Disease will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, to be held virtually and in Boston, MA, April 22-27, 2023.

Details for the presentations are as follows:

New Poster - Multi-Modal Correlation Analyses from a Phase 2, Open-Label Study of NE3107 in Patients with Cognitive Decline Due to Degenerative Dementias

• Presentation date/time: 4/25/23 @8:00-9:00am ET
• Presenter: Joseph Palumbo
• Abstract: https://www.aan.com/MSA/Public/Events/AbstractDetails/54170
  

Encore Poster - Clinical Outcomes from a Phase 2, Open-Label Study of NE3107 in Patients with Cognitive Decline Due to Degenerative Dementias

• Presentation date/time: 4/25/23 @11:45am-12:45pm ET
• Presenter: Kaya Jordan
• Abstract: https://www.aan.com/MSA/Public/Events/AbstractDetails/54177
  

Encore Poster - Safety, Tolerability, and Efficacy of NE3107 from a Phase 2, Double-Blind, Placebo-Controlled Study in Levodopa/Carbidopa-Treated Patients with Parkinson's Disease

• Presentation date/time: 4/23/23 @8:00-9:00am ET
• Presenter: Nilab Osman
• Abstract: https://www.aan.com/MSA/Public/Events/AbstractDetails/54740
  

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 are the Phase 2 trial results for NE3107 announced by BioVie?

BioVie revealed promising data for NE3107 in treating degenerative dementias and Parkinson’s disease, with results to be presented at the AAN Annual Meeting.

When will BioVie present its findings on NE3107?

BioVie will present its findings on April 25, 2023, at the 2023 AAN Annual Meeting.

What is the significance of the FDA Fast Track status for BIV201?

The FDA Fast Track status for BIV201 indicates that it may benefit from expedited review processes, potentially accelerating its availability for patients.

What are the next steps for BioVie following the Phase 2 trial results?

BioVie plans to continue its clinical trials, including a Phase 3 study of NE3107 in Alzheimer's patients.