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BioVie Highlighted ADDRESS-LC Phase 2 Trial Design Exploring Bezisterim for the Treatment of Neurological Symptoms of Long COVID at Keystone Symposia on Long COVID and Other Post-Acute Infection Syndromes
Globenewswire· 2025-08-13 20:05
Core Insights - BioVie Inc. is conducting a Phase 2 trial named ADDRESS-LC to evaluate the efficacy of bezisterim for treating Long COVID-related fatigue and cognitive impairment [1][2][10] - Long COVID is recognized as a significant neurological condition affecting approximately 400 million individuals globally, with 6.9% of U.S. adults experiencing it [2] - Bezisterim is an anti-inflammatory agent that targets TLR-driven inflammation, showing promise in treating Long COVID, Alzheimer's disease, and Parkinson's disease [3][8] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and Long COVID [13] - The company’s drug candidate, bezisterim, modulates inflammation and insulin sensitivity, potentially improving clinical outcomes in various neurological conditions [7][13] Trial Design and Funding - The ADDRESS-LC trial is a multicenter, double-blind, randomized, placebo-controlled study, fully funded by a $13.13 million grant from the U.S. Department of Defense [2][12] - The trial incorporates a unique design informed by patient input, aiming to address the unmet needs of Long COVID patients and enhance signal detection for treatment efficacy [4][5] Bezisterim's Mechanism and Clinical Potential - Bezisterim is designed to inhibit TLR4-induced signaling and inflammatory pathways, making it a candidate for reducing neurocognitive symptoms associated with Long COVID [3][10] - The drug has demonstrated a favorable safety and tolerability profile in previous clinical trials for Alzheimer's and Parkinson's diseases [3][9] Key Trial Endpoints - The primary endpoints of the ADDRESS-LC trial include changes in cognitive performance measured by a bespoke Cogstate Cognitive Battery, focusing on symptoms like cognitive impairment and fatigue [5][10]
BioVie Inc. Announces Pricing of $12 Million Public Offering
Globenewswire· 2025-08-08 00:43
Core Viewpoint - BioVie Inc. has announced a public offering of 6,000,000 units at a price of $2.00 per unit, aiming to raise approximately $12 million for working capital and general corporate purposes [1][2]. Group 1: Offering Details - Each unit consists of one share of common stock and one warrant, with pre-funded units available [1]. - The gross proceeds from the offering are expected to be around $12 million before deducting underwriting discounts and commissions [1]. - The warrants will be immediately exercisable at an exercise price of $2.50 per share and will expire five years from issuance [1]. - The underwriter has a 45-day option to purchase up to an additional 900,000 shares or warrants to cover over-allotments [1]. Group 2: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for chronic debilitating conditions, including liver disease and neurological disorders [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in Alzheimer's and Parkinson's diseases [5]. - BioVie’s orphan drug candidate BIV201 is under evaluation for treating liver cirrhosis and ascites, with FDA Fast Track status [5].
BioVie Presented Data Highlighting that Patients Treated with Bezisterim Potentially Experienced an Age Deceleration Advantage Compared to Placebo on 10 Different Biological Clocks at the 2nd World Conference on Aging and Gerontology
Globenewswire· 2025-07-24 12:00
Core Insights - BioVie Inc. presented findings on Bezisterim, indicating its potential to decrease biological age acceleration in Alzheimer's Disease by modulating DNA methylation of over 100 genes related to aging and diseases of aging [1][4]. Group 1: Bezisterim's Mechanism and Effects - Bezisterim modulates TNFα-driven inflammation, helping to reestablish homeostasis and affecting multiple genes simultaneously [4]. - The treatment resulted in significant age deceleration across various biological clocks after 30 weeks, including reductions of -3.16 years for SkinBloodClockAge and -4.12 years for PhenoAge [5]. - Bezisterim demonstrated modulation of inflammatory gene expression, reducing levels of inflammatory cytokines such as TNFα, IL-6, and IL-17 [5]. Group 2: Clinical Trials and Efficacy - BioVie is conducting ongoing studies to explore Bezisterim's potential in improving healthspan in normal aging and its effects on neurodegenerative diseases [4]. - In Alzheimer's Disease, Bezisterim-treated patients showed improved cognition and biomarker levels in a Phase 2 trial, with significant improvements in metabolic and inflammatory biomarkers compared to placebo [10][11]. - The company is also enrolling patients in a Phase 2 trial for Parkinson's Disease, with topline data expected in late 2025 or early 2026 [8]. Group 3: Safety and Tolerability - Bezisterim is not immunosuppressive and has shown favorable safety and tolerability profiles in clinical trials for Alzheimer's Disease and Parkinson's Disease [6][7].
BioVie Announces Data Highlighting Bezisterim’s Potential to Slow or Reverse Biological Aging and Neurodegeneration Featured as a Keynote Talk at the 7th World Aging and Rejuvenation Conference
Globenewswire· 2025-07-09 12:00
Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim, which shows promise in treating neurological disorders, particularly Alzheimer's disease, Parkinson's disease, and long COVID, by modulating inflammation and potentially altering biological aging [1][9]. Group 1: Bezisterim's Mechanism and Effects - Bezisterim differs from traditional Alzheimer's treatments by modulating inflammation and affecting multiple genes simultaneously, potentially altering biological age through anti-inflammatory epigenetic modifications [2][3]. - In a Phase 3 study, bezisterim demonstrated significant effects on biological aging, with bezisterim-treated patients showing an average biological age reduction of -3.16 years for SBCAge and -4.12 years for PhenoAge compared to placebo [5]. - Bezisterim has shown improvements in metabolic and inflammatory biomarkers, including a decrease of -8.5 mg/dL in fasting glucose and -15 mg/dL in cholesterol levels compared to placebo [5]. Group 2: Clinical Trials and Studies - The ongoing Phase 2 SUNRISE-PD trial is evaluating bezisterim's safety and efficacy in Parkinson's disease, with topline data expected in late 2025 or early 2026 [5]. - Previous studies indicated that bezisterim improved motor control in Parkinson's patients when combined with levodopa, with no adverse events reported [6]. - The Phase 2 ADDRESS-LC study aims to assess bezisterim's efficacy in reducing neurological symptoms associated with long COVID, targeting cognitive dysfunction and fatigue [7]. Group 3: Company Overview and Future Directions - BioVie Inc. focuses on developing innovative therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance, key factors in Alzheimer's and Parkinson's diseases [9]. - The company is also advancing its orphan drug candidate BIV201 for liver cirrhosis, which has received FDA Fast Track status [9].