CARSON CITY, Nev., July 09, 2025 (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, presented "Bezisterim Epigenetic Effects on Aging and Neurodegeneration" at the 7th World Aging and Rejuvenation Conference (ARC-2025) taking place in Vienna, Austria, July 9th –10th, 2025. Unlike historical approach to Alzheimer's Disease (AD) tr ...

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of early Parkinson's disease, with a Phase 2 SUNRISE-PD trial set to present findings at an upcoming congress [1][2]. Company Overview - BioVie Inc. (NASDAQ: BIVI) focuses on developing innovative therapies for neurological disorders, including Alzheimer's disease, Parkinson's disease, and long COVID, as well as advanced liver disease [12]. - The company's lead candidate, bezisterim, is designed to modulate inflammation and enhance insulin sensitivity without immunosuppressive effects [7][12]. Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study lasting 20 weeks, allowing patients to participate either from home or at clinical sites [2][3]. - The trial aims to evaluate the safety and efficacy of bezisterim on both motor and non-motor symptoms in patients not previously treated with carbidopa/levodopa, with topline data expected in late 2025 or early 2026 [8]. Parkinson's Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact quality of life [4]. - Traditional treatment with levodopa has limitations, including motor fluctuations and dyskinesia, highlighting the need for new therapeutic approaches [5]. Mechanism of Action - Bezisterim targets neuroinflammation and insulin resistance, which are implicated in the progression of Parkinson's disease, potentially offering a new treatment avenue [6][7]. Previous Research Findings - A prior Phase 2 study of bezisterim showed significant improvements in motor control and "morning on" symptoms when combined with levodopa, with no drug-related adverse events reported [9].

Core Viewpoint - Long COVID is increasingly recognized as a serious condition affecting millions, with no approved treatment options currently available, highlighting the urgent need for effective therapies [1][2][4] Group 1: Long COVID Overview - Long COVID impacts approximately 20 million adults in the U.S. and millions more globally, with 10-30% of COVID-19 patients experiencing lingering symptoms such as fatigue and cognitive impairment [2][5] - The economic impact of long COVID is significant, estimated at $3.7 trillion due to loss in quality of life, earnings, and increased medical costs [5] Group 2: Bezisterim Development - BioVie Inc. has initiated the Phase 2 ADDRESS-LC clinical trial to evaluate bezisterim (NE3107) for treating neurological symptoms associated with long COVID, with topline data expected in the first half of 2026 [1][3] - Bezisterim targets neuroinflammation, which is believed to play a central role in long COVID symptoms, and has shown potential in reducing chronic symptoms in trials for Alzheimer's and Parkinson's diseases [1][3][6] Group 3: Clinical Trial Details - The ADDRESS-LC study is a randomized, placebo-controlled trial involving approximately 200 patients with long COVID experiencing cognitive impairment and fatigue [3][8] - The trial is fully funded by a $13.13 million grant from the U.S. Department of Defense [10] Group 4: Mechanism of Action - Bezisterim is an orally bioavailable, blood-brain barrier-permeable compound that modulates inflammatory pathways implicated in chronic inflammation, potentially improving symptoms in long COVID patients [6][8] - The drug is designed to reduce neuroinflammation and address metabolic dysfunction, which may help restore normal function and improve quality of life for affected individuals [3][4] Group 5: Broader Implications - The persistent presence of SARS-CoV-2 proteins and the resulting inflammatory pathways are linked to prolonged neuroinflammation and symptoms in long COVID patients, indicating a need for targeted interventions [4][8] - BioVie is also conducting trials for bezisterim in Parkinson's and Alzheimer's diseases, demonstrating its broader therapeutic potential [7][9]

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of early Parkinson's disease, with a Phase 2 clinical trial named SUNRISE-PD set to present findings at the IAPRD 2025 conference in New York City [1][2]. Company Overview - BioVie Inc. (NASDAQ: BIVI) focuses on developing innovative drug therapies for neurological and neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and long COVID, as well as advanced liver disease [13]. - The company's lead candidate, bezisterim, is designed to modulate inflammation and enhance insulin sensitivity without immunosuppressive effects, potentially addressing multiple disease indications [8][13]. Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study lasting 20 weeks, evaluating bezisterim's safety and efficacy in patients with early Parkinson's disease [3][4]. - Patients can participate either from home or at clinical sites, with remote supervision by neurologists during assessments [4]. Parkinson's Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact patients' quality of life [5]. - Traditional treatments like levodopa have limitations, including long-term complications such as motor fluctuations and dyskinesia [6]. Mechanism of Action - Bezisterim targets chronic inflammation and insulin resistance, which are linked to the progression of Parkinson's disease, by modulating neuroinflammation and metabolic dysfunctions [7][8]. Expected Outcomes - Topline data from the SUNRISE-PD trial is anticipated in late 2025 or early 2026, with previous studies indicating bezisterim's potential to improve motor control and reduce adverse events when combined with levodopa [9][10].

Core Insights - BioVie Inc. has initiated patient enrollment for the Phase 2 SUNRISE-PD clinical trial, which evaluates the safety and efficacy of bezisterim in patients with Parkinson's disease who have not been treated with carbidopa/levodopa, with topline data expected in late 2024 or early 2025 [2][4][7] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Parkinson's disease, Alzheimer's disease, and long COVID [14][15] - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer and anti-inflammatory drug candidate that may provide clinical improvements in various disease indications [11][14] Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study designed to last 20 weeks, with approximately 60 patients randomized to receive either 20 mg of bezisterim or placebo twice daily [4][5] - The trial incorporates a decentralized approach, allowing patients to participate remotely, which broadens access for individuals with Parkinson's disease [4][6][7] Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms, with current treatments primarily providing symptomatic relief without modifying disease progression [3][8][9] - Emerging research indicates that chronic inflammation and insulin resistance play critical roles in the onset and progression of Parkinson's disease, suggesting that targeting these mechanisms may offer new therapeutic avenues [10][12] Support and Collaboration - Patient enrollment for the SUNRISE-PD trial is supported by prominent advocacy groups, including The Michael J. Fox Foundation, Davis Phinney Foundation, and The Parkinson's Foundation, emphasizing the importance of increased patient access to clinical trials [2][7][6]