BioVie Announces Data from Phase 2 Parkinson’s Disease Trial Accepted for Presentation at AD/PD 2023

Rhea-AI Summary

BioVie Inc. (NASDAQ: BIVI) announced that data from its Phase 2 trial of NE3107 in Parkinson's Disease will be presented at the AD/PD 2023 conference in Gothenburg, Sweden, from March 28 to April 1, 2023. The oral presentation will discuss the Safety, Tolerability, and Efficacy of NE3107 in patients treated with levodopa/carbidopa. Additionally, a poster presentation will cover the pharmacokinetic profile of NE3107. The trial results indicated that NE3107 may improve motor control without causing adverse events. BioVie is also conducting a Phase 3 study for NE3107 in Alzheimer's disease and a Phase 2b study for BIV201 in patients with liver cirrhosis.

Positive

• Phase 2 trial data shows clinically meaningful improvement in motor control in Parkinson's patients when combined with levodopa.
• No drug-related adverse events reported during the trial.
• Upcoming presentation at AD/PD 2023 enhances visibility and credibility for NE3107.

Negative

• None.

CARSON CITY, Nev., March 21, 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 from its Phase 2 Parkinson’s Disease (PD) trial will be presented at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD 2023), to be held March 28 – April 1, 2023 in Gothenburg, Sweden.

Data from the Company’s Phase 2 Trial evaluating NE3107 in Parkinson’s Disease will be presented orally during the symposium Advances in PD and LDB Diagnosis and Drug Development (ID#124). A poster presentation on the pharmacokinetic profile of NE3107 will also be given. Both the oral presentation and poster will be available virtually throughout the event.

Details for the presentations are as follows:

Oral Presentation
Title - Safety, Tolerability, and Efficacy of NE3107 From A Phase 2, Double-Blind, Placebo-Controlled Study In Levodopa/Carbidopa-Treated Patients with Parkinson's Disease
Date/Time - Saturday, April 1, 4:00pm Local Time (Hall F1+F2+F3)
Presenter - Christopher Reading, PhD

Poster Presentation
Title - Effect of NE3107 on the Pharmacokinetics Profile of Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2, Double-Blind, Placebo-Controlled Study
Authors: Clarence Ahlem; Christopher Reading, PhD; Joseph Djan; Joseph Palumbo, MD

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 topline data released in December 2022, showed 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 2 trial and details regarding the launch of its 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 key results from BioVie Inc.'s Phase 2 trial for NE3107 in Parkinson's Disease?

The Phase 2 trial of NE3107 showed clinically meaningful improvement in motor control in patients treated with NE3107 alongside levodopa, without any reported adverse events.

When will BioVie present the NE3107 trial data?

BioVie Inc. will present the data at the International Conference on Alzheimer's and Parkinson's Diseases from March 28 to April 1, 2023.

What is the focus of BioVie's NE3107 trial presentations?

The presentations will focus on the safety, tolerability, and efficacy of NE3107 in treating Parkinson's Disease.

What other studies is BioVie conducting aside from the Phase 2 trial for Parkinson's Disease?

BioVie is also conducting a Phase 3 trial of NE3107 for Alzheimer's disease and a Phase 2b study for BIV201 in treating liver cirrhosis.

How does NE3107 work in treating neurodegenerative disorders?

NE3107 aims to inhibit inflammatory activation linked to neuroinflammation and insulin resistance, which are drivers of Alzheimer's and Parkinson's diseases.