Core Points - BioVie Inc. has executed a reverse stock split of its Class A common stock at a ratio of 1-for-10, effective immediately [1][2] - The company's common stock will continue to trade on The Nasdaq Capital Market under the symbol "BIVI" with a new CUSIP number of 09074F405 [1] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease [3] - The drug candidate bezisterim targets neuroinflammation and insulin resistance, which are associated with Alzheimer's disease (AD) and Parkinson's disease (PD) [3] - The orphan drug candidate BIV201, which has received FDA Fast Track status, is being evaluated for the treatment of ascites due to chronic liver cirrhosis [3] - BIV201 is already approved in the U.S. and approximately 40 other countries for related complications of advanced liver cirrhosis [3]

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of Parkinson's disease, with a focus on both motor and non-motor symptoms, as highlighted in recent presentations at the ATMRD Congress [1][2][3]. Study Design and Objectives - The upcoming SUNRISE-PD trial is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate bezisterim in approximately 60 patients with early Parkinson's disease who have had minimal prior exposure to carbidopa/levodopa [4][5]. - The trial will last 20 weeks, including a 12-week double-blind phase where patients will be randomized to receive either bezisterim 20 mg or placebo twice daily [4][10]. Key Endpoints - The primary objective is to evaluate the efficacy of bezisterim in treating motor symptoms, specifically measuring changes in the MDS-UPDRS Part III score at week 12 [6][8]. - Secondary objectives include assessing the impact on non-motor symptoms, overall symptoms, and safety and tolerability of bezisterim [6][7][10]. Previous Trial Data - Data from a Phase 2a trial indicated that bezisterim, when used adjunctively with carbidopa/levodopa, showed improvements in both motor and non-motor symptoms of Parkinson's disease [11][12]. - Patients treated with bezisterim experienced a statistically significant improvement in MDS-UPDRS Part III scores compared to placebo, particularly in patients younger than 70 years [12][13]. Mechanism of Action - Bezisterim is characterized as an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties, potentially addressing inflammation and insulin resistance associated with Parkinson's disease [15][17]. Broader Implications - The ongoing research into bezisterim also includes investigations for Alzheimer's disease, with previous studies showing promising results in cognitive function and biomarker levels [16][17].

CARSON CITY, Nev., June 20, 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 two poster presentations at the Advanced Therapeutics in Movement and Related Disorders Congress® (ATMRD Congress) being held June 21-25, 2024 in Washington, D.C. The presentation Assessment of Bezisterim (NE3107) in Patients with ...

Core Insights - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease [1][4] Group 1: Company Developments - BioVie announced two poster presentations at the Advanced Therapeutics in Movement and Related Disorders Congress, scheduled for June 21-25, 2024 [1] - The presentations will include data on bezisterim's impact on motor and non-motor symptoms in Parkinson's disease, showcasing results from a Phase 2a, placebo-controlled study [2][7] - Bezisterim is also being investigated for Alzheimer's disease, with previous studies indicating improved cognition and biomarker levels in treated patients [3][4] Group 2: Drug Candidates - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable insulin-sensitizer that exhibits anti-inflammatory properties and has a low risk of drug-to-drug interactions [9] - The drug candidate is designed to inhibit inflammatory activation linked to neurodegenerative diseases, specifically targeting pathways that lead to neuroinflammation and insulin resistance [4] - BIV201, another drug candidate for liver disease, has received FDA Fast Track status and is being prepared for Phase 3 clinical testing for treating ascites due to chronic liver cirrhosis [4]

"We are gratified to have been selected and to have received funding from the DoD to evaluate our novel therapeutic bezisterim in patients with Long COVID," said Dr. Palumbo. "Bezisterim is an anti-inflammatory and insulin-sensitizer that permeates the blood-brain barrier and could represent a novel oral treatment targeting an underlying cause of long COVID symptoms. Our Scientific Advisory Board will play a pivotal role in guiding and accelerating our program in the currently funded planning phase. We are ...

Core Insights - BioVie Inc. announced significant improvements in both non-motor and motor symptoms for Parkinson's Disease patients treated with bezisterim compared to those on placebo, indicating the potential of bezisterim as an adjunct therapy to levodopa [1][4] Group 1: Study Findings - The Phase 2a trial data presented at the XXIX World Congress on Parkinson's Disease showed that bezisterim-treated patients had a -2.8 point advantage on the MDS-UPDRS Motor score compared to placebo [3] - In patients younger than 70 years, the advantage increased to -4.7 points, with 30% of bezisterim-treated patients showing improved morning Part 3 scores, while none in the placebo group showed similar improvements [3] - Bezisterim-treated patients experienced a significant improvement of -2.4 points in the sleep/fatigue domain of the NMSS, while placebo patients worsened by +1.0 points [3] Group 2: Mechanism and Potential - Bezisterim is an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties, showing potential to reduce symptoms of long COVID and modulate inflammation [5] - The drug is being investigated for both Alzheimer's disease and Parkinson's disease, with previous studies indicating improvements in motor control and cognition [6][7] Group 3: Company Overview - BioVie Inc. is focused on developing innovative drug therapies for neurological and neurodegenerative disorders, with bezisterim targeting neuroinflammation and insulin resistance [8] - The company is also evaluating BIV201 for advanced liver disease, which has received FDA Fast Track status [8]

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About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Increasing evidence supports a role for viral persistence, chronic inflammation and immune and metabolic dysregulation in driving long COVID Bezisterim, an anti-inflammatory and insulin-sensitizer that permeates the blood brain barrier, could represent a novel oral treatment targeting an underlying cause of long COVID symptoms CARSON CITY, Nev., April 29, 2024 (GLOBE NEWSWIRE) --  BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the tr ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...