BioVie
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 13
- Market Cap
- -
- Introduction
BioVie, Inc. is a biopharmaceutical company, which engages in discovery, development, and marketing drug therapies for neurological and neurodegenerative disorders and liver disease. The company was founded on April 10, 2013 and is headquartered in Carson City, NV.
BioVie Initiates Phase 2 Trial of Bezisterim for Long COVID Neurological Symptoms
• BioVie has enrolled the first patient in its Phase 2 ADDRESS-LC trial evaluating bezisterim for neurological symptoms of long COVID, with topline data expected in the first half of 2026.
• Long COVID affects approximately 20 million adults in the US alone, with 10-30% of COVID-19 patients experiencing persistent symptoms including fatigue and cognitive impairment, yet no FDA-approved treatments exist.
• Bezisterim targets neuroinflammation by modulating NF-κB activation and TNF-α production, pathways implicated in both long COVID and neurodegenerative diseases like Alzheimer's and Parkinson's.
BioVie Launches SUNRISE-PD Trial to Test Novel Anti-inflammatory Approach for Early Parkinson's Disease
• BioVie has enrolled the first patient in its Phase 2 SUNRISE-PD trial evaluating bezisterim, an anti-inflammatory and insulin-sensitizing drug candidate, in early-stage Parkinson's disease patients who haven't received carbidopa/levodopa treatment.
• The innovative trial features a hybrid decentralized design allowing patients to participate remotely from home, with support from major foundations including The Michael J. Fox Foundation, potentially expanding access to clinical research.
• Bezisterim targets underlying inflammation and insulin resistance mechanisms implicated in Parkinson's disease progression, offering a potential alternative to traditional dopamine-replacement therapies that only provide symptomatic relief.
European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns
• The European Medicines Agency's advisory committee has recommended against approving Eli Lilly's Alzheimer's treatment Kisunla, citing safety concerns related to brain swelling.
• European regulators determined that the risks of amyloid-related imaging abnormalities (ARIA) outweigh the potential benefits of the drug, creating a notable divergence from US regulatory decisions.
• This rejection marks another instance where European and American regulators have reached different conclusions on new Alzheimer's treatments, highlighting regional differences in benefit-risk assessment.
Vivani Medical to Spin Off Cortigent Neurostimulation Business as Independent Public Company
• Vivani Medical plans to spin off its Cortigent neurostimulation division as an independent Nasdaq-listed company by Q3 2025, allowing each entity to focus on their distinct therapeutic areas.
• Cortigent's technology includes the Orion® artificial vision system for blindness, which completed a 6-year clinical study in 2024 with promising results, and applications for stroke recovery.
• Post-spinoff, Vivani will concentrate exclusively on developing its proprietary NanoPortal™ GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration.
Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development
• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases.
• Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact.
• MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned.
• The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.
BioVie's Bezisterim to Enter Phase 2 Trial for Long COVID Treatment
• BioVie Inc. will present the design of its Phase 2 trial of bezisterim for Long COVID at the Demystifying Long COVID International Conference.
• The Phase 2 study is a double-blind, randomized, placebo-controlled, multicenter trial involving approximately 200 patients.
• Bezisterim's efficacy in reducing neurocognitive symptoms associated with Long COVID will be evaluated over a 3-month treatment period.
• The trial is fully funded by a $13.1 million grant from the U.S. Department of Defense.
Parkinson's Disease Research Focuses on Disease-Modifying Therapies
• The Parkinson's disease (PD) therapeutic market faces unmet needs, notably the absence of neuroprotective/disease-modifying therapies (DMTs) and treatments for non-motor symptoms.
• A significant portion of the PD drug development pipeline is dedicated to neuroprotective and disease-modifying agents, targeting mechanisms like alpha-synuclein aggregation and neuroinflammation.
• Clinical trials are underway for therapies addressing postural instability, PD-dementia, and cognitive/emotional impairments, reflecting a comprehensive approach to managing PD's complexities.
BioVie to Host Investor Webinar on November 7th, 2024, to Discuss Clinical Programs
• BioVie Inc. will host an investor webinar on November 7, 2024, to discuss its clinical programs in Parkinson's disease, long COVID, Alzheimer's disease, and ascites associated with advanced liver disease.
• The webinar will feature Cuong Do, President and CEO of BioVie, who will provide insights on the company's mid-to-late-stage clinical programs.
• BioVie's lead asset, bezisterim, has shown promise in modulating TNFα production and improving clinical outcomes in Parkinson's and Alzheimer's diseases.
• The company plans to launch Phase 2b trials for Parkinson's disease and long COVID, and a Phase 3 trial for Alzheimer's disease, while also seeking partnerships for BIV201 in ascites.
Alzheimer's Disease and Gene Therapy Clinical Trials Show Promise with Novel Approaches
• Over 120 Alzheimer's Disease treatment therapies are under development globally, targeting various mechanisms of action and routes of administration.
• Gene therapy is emerging as a potential treatment strategy, with over 300 gene therapy drugs in the pipeline for various diseases, including neurological disorders.
• Several companies are advancing Alzheimer's therapies through clinical trials, including Phase 3 studies for small molecule candidates and Phase 1 trials for novel muscarinic agonists.
• Recent FDA approval of Leqembi marks a significant milestone, highlighting the potential of amyloid beta-directed antibodies in treating Alzheimer's disease.
BioVie's Bezisterim Receives Final Approval for Phase 2 Long COVID Trial
• BioVie Inc. has secured the final scientific approval from the U.S. Army for its Phase 2 trial evaluating bezisterim in treating neurological symptoms associated with long COVID.
• The Phase 2 trial, expected to commence by early 2025, is a randomized, placebo-controlled study involving approximately 200 patients.
• Bezisterim, an oral anti-inflammatory and insulin-sensitizing agent, targets chronic inflammation and blood-brain barrier dysfunction, key features of long COVID.
• The trial is supported by a $12.6 million grant from the Department of Defense, adding to an initial $499,200 for the planning phase.
International Research Team Proposes Multimodal Treatment Strategy for Long COVID and Post-Acute Infectious Syndromes
• An international research team has developed a comprehensive treatment approach combining pharmacological and physical therapies for post-acute infectious syndromes, including long COVID.
• Metformin and low-dose naltrexone showed promising results in treating long COVID symptoms, with metformin demonstrating reduced diagnosis rates in a double-blind trial.
• The multimodal strategy includes physical interventions like extracorporeal apheresis, which improved symptoms in 70% of long COVID patients in clinical studies.
FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump
• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older.
• Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older.
• Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.
FDA Authorizes Phase 2 Trial of Bezisterim for Neurological Symptoms of Long COVID
• BioVie Inc. received FDA authorization for an Investigational New Drug application to study bezisterim (NE3107) in treating neurological symptoms associated with long COVID.
• The Phase 2 trial will involve approximately 200 patients randomized to assess the safety and tolerability of bezisterim over three months, focusing on reducing neurocognitive symptoms.
• Bezisterim, an orally bioavailable insulin sensitizer with anti-inflammatory properties, modulates NFkB activation, potentially addressing inflammation, a key driver of long COVID.
• Current estimates suggest that 5.5% of US adults have long COVID, highlighting the urgent need for effective treatments, with bezisterim also under investigation for Alzheimer's and Parkinson's diseases.
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