Core Viewpoint - BioVie Inc. has received approval from the U.S. Army Medical Research and Development Command for its plan to evaluate bezisterim for treating neurological symptoms associated with long COVID, which is a significant step towards receiving $12.6 million in grant funding and initiating Phase 2 trials by early 2025 [1][2]. Group 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 [10]. - The company's drug candidate, bezisterim, is an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties [7][8]. - Bezisterim is also being investigated for Alzheimer's disease and Parkinson's disease, with positive efficacy data reported from previous trials [9]. Group 2: Long COVID Context - Long COVID affects over 17 million adults in the U.S., with symptoms persisting for three months or more, including cognitive dysfunction and fatigue [3][5]. - Chronic inflammation is a key hypothesis for the persistence of long COVID symptoms, with specific physiological features such as blood-brain barrier dysfunction being significant [6]. - Bezisterim targets inflammation and BBB integrity, potentially addressing the underlying causes of long COVID symptoms [8][6]. Group 3: Clinical Trial Details - The planned Phase 2 study will be a randomized, placebo-controlled trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over three months [2]. - The study aims to evaluate the reduction of neurocognitive symptoms associated with long COVID [2]. - The Department of Defense has allocated $499,200 for the planning phase, with the potential for an additional $12.6 million to initiate the clinical trial [4].

Core Viewpoint - BioVie Inc. has received FDA authorization for its IND application to evaluate bezisterim for treating neurological symptoms associated with long COVID, marking a significant milestone ahead of schedule [1][2]. Group 1: Company Developments - BioVie is set to receive an additional $12.6 million in grant funding from the U.S. Department of Defense to initiate a Phase 2 trial for bezisterim [1][4]. - The planned Phase 2 study will involve approximately 200 patients in a randomized, placebo-controlled trial to assess the safety and tolerability of bezisterim over three months [2]. Group 2: Long COVID Overview - Long COVID affects approximately 5.5% of U.S. adults, with around 3.6 million individuals reporting significant modifications to their daily activities due to the condition [3][5]. - Symptoms of long COVID include cognitive dysfunction and fatigue, with chronic inflammation being a key hypothesis for the persistence of these symptoms [3][6]. Group 3: Bezisterim Details - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable drug that acts as an insulin-sensitizer and anti-inflammatory, potentially reducing long COVID symptoms [7]. - The drug has shown promise in modulating inflammation through the activation of NF-kB, targeting underlying causes of long COVID symptoms [7]. Group 4: Broader Implications - The economic impact of long COVID is substantial, estimated at $3.7 trillion due to loss in quality of life, earnings, and increased medical costs [5]. - Bezisterim is also being investigated for its efficacy in treating Alzheimer's disease and Parkinson's disease, with positive results reported in clinical trials [8].

Core Insights - Bezisterim demonstrates significant potential in modulating biological aging and inflammation, showing a 2 to 4 years age deceleration advantage in patients compared to placebo [1][3][11] Group 1: Clinical Data and Findings - Clinical data presented at the 11th Aging Research and Drug Discovery Meeting indicates that bezisterim affects biological aging and chronic low-grade inflammation [2][3] - Patients treated with bezisterim exhibited age deceleration advantages across various biological clocks: 3.68 years on SkinBlood Clock, 4.77 years on Inflammation Age Clock, 5.0 years on Hannum Age Clock, 1.92 years on GrimAge Clock, and 3.71 years on PhenoAge Clock [3][11] - Bezisterim is associated with 1.5 to 2.3 "fold enrichment" in gene pathways related to neurodegenerative disorders, indicating its potential to influence gene expression significantly [4][9] Group 2: Mechanism of Action - Bezisterim modulates DNA methylation of proinflammatory genes, promoting the transition from M1 proinflammatory macrophages to M2 anti-inflammatory macrophages [1][3][9] - The drug has shown the ability to significantly modulate the methylation levels of genes involved in inflammatory pathways, potentially reducing the production of inflammatory factors such as TNFα and IL6 [4][9][10] - Bezisterim is believed to be the first drug candidate to demonstrate an impact on DNA methylation and age deceleration in a clinical trial context [3][5] Group 3: 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 [12] - The company is investigating bezisterim for conditions such as Alzheimer's disease and Parkinson's disease, with promising results from Phase 2 and Phase 3 clinical trials [11][12] - BioVie is also developing BIV201, an orphan drug candidate for treating ascites due to chronic liver cirrhosis, which has received FDA Fast Track status [12]

CARSON CITY, Nev., Aug. 06, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or the "Company") today announced that the Company's reverse stock split of its issued and outstanding Class A common stock ("Common Stock"), at an exchange ratio of 1-for-10, is now effective. The Company's Common Stock began trading on a split-adjusted basis and will remain listed on The Nasdaq Capital Market under the symbol "BIVI". The new CUSIP number for the Company's Common Stock following the reverse stock spli ...

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]