Hybrid, decentralized trial of bezisterim in early Parkinson’s Disease prioritizes patient access and participationCARSON CITY, Nev., June 26, 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, today announced that a poster highlighting the patient-centric design and accessibility of its ongoing SUNRISE-PD Phase 2 clinical t ...

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]