BioVie Secures All Scientific Approvals Needed to Receive Additional $12.6 Million of Grant Funding to Launch Planned Phase 2 Trial to Evaluate Bezisterim in Long COVID

Core Viewpoint - BioVie Inc. has received approval from the U.S. Army Medical Research and Development Command for its plan to evaluate bezisterim for treating neurological symptoms associated with long COVID, which is a significant step towards receiving $12.6 million in grant funding and initiating Phase 2 trials by early 2025 [1][2]. Group 1: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease [10]. - The company's drug candidate, bezisterim, is an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties [7][8]. - Bezisterim is also being investigated for Alzheimer's disease and Parkinson's disease, with positive efficacy data reported from previous trials [9]. Group 2: Long COVID Context - Long COVID affects over 17 million adults in the U.S., with symptoms persisting for three months or more, including cognitive dysfunction and fatigue [3][5]. - Chronic inflammation is a key hypothesis for the persistence of long COVID symptoms, with specific physiological features such as blood-brain barrier dysfunction being significant [6]. - Bezisterim targets inflammation and BBB integrity, potentially addressing the underlying causes of long COVID symptoms [8][6]. Group 3: Clinical Trial Details - The planned Phase 2 study will be a randomized, placebo-controlled trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over three months [2]. - The study aims to evaluate the reduction of neurocognitive symptoms associated with long COVID [2]. - The Department of Defense has allocated $499,200 for the planning phase, with the potential for an additional $12.6 million to initiate the clinical trial [4].