BioVie Announces FDA Authorization of Investigational New Drug Application for Phase 2 Trial to Evaluate Bezisterim in Long COVID

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].