BioVie Forms Advisory Board for Bezisterim in Long COVID

BioVie Inc. (NASDAQ: BIVI), a clinical-stage pharmaceutical company focusing on neurological and liver diseases, announced the formation of a long COVID Advisory Board. This board aims to provide strategic direction for a Phase 2b trial in long COVID patients, supported by funding from the U.S. Department of Defense.

Long COVID refers to persistent symptoms following an acute COVID-19 infection, lasting for three months or more. Symptoms often involve cognitive dysfunction and fatigue, and currently, there are no proven treatments. The Centers for Disease Control reports over 17 million adults in the U.S. have experienced or are experiencing long COVID.

The Advisory Board comprises six experts, including leading infectious disease researchers Michael Peluso, MD, MHS, and Steven Deeks, MD from the University of California, San Francisco; neurologists Sherry Chou, MD, and Igor Koralnik, MD from Northwestern Feinberg School of Medicine; and industry specialists Cynthia Girman, Dr. PH, and Dr. Douglas Feltner. BioVie's Chief Medical Officer, Joseph Palumbo, MD, will chair the board.

Dr. Palumbo expressed gratitude for the Department of Defense funding, emphasizing the potential of their therapeutic candidate, bezisterim, an anti-inflammatory and insulin-sensitizer that crosses the blood-brain barrier. This drug could address a root cause of long COVID symptoms. The Advisory Board will guide the planning phase, aiming to accelerate the program.

The board members bring extensive expertise. Drs. Peluso and Deeks have spearheaded the LIINC study, which explores long-term COVID impacts, and oversee the NIH’s RECOVER initiative. Drs. Chou and Koralnik are pioneers in studying COVID-19’s neurological effects, leading major studies and clinics focused on these complications. Dr. Girman has four decades of experience in epidemiology and biostatistics, specializing in real-world evidence and clinical trial methodologies. Dr. Feltner is a veteran in drug development with a focus on neurological and psychiatric conditions.

Bezisterim has shown potential in modulating inflammation and improving insulin sensitivity without immunosuppression. This makes it a promising candidate for reducing long COVID symptoms, such as cognitive issues and fatigue. The upcoming Phase 2b trial will be a randomized, placebo-controlled study involving approximately 200 patients. It aims to evaluate the safety and efficacy of bezisterim over a three-month treatment period.

The Department of Defense award provides $499,200 for the planning phase, with an option for an additional $12.6 million contingent on meeting specific milestones and regulatory approvals. This funding is part of the Peer-Reviewed Medical Research Program under Award No. HT9425-24-1-0113.

Long COVID, characterized by lingering symptoms from a COVID-19 infection, affects millions and has significant economic implications, estimated at $3.7 trillion. Chronic inflammation and blood-brain barrier dysfunction are believed to contribute to these persistent symptoms. Bezisterim’s ability to modulate inflammation and maintain blood-brain barrier integrity positions it as a potential treatment for the neurological aspects of long COVID.

BioVie Inc. is dedicated to developing therapies for neurological and liver diseases. Their drug candidate, bezisterim, targets inflammation and insulin resistance, key factors in conditions like Alzheimer's and Parkinson's diseases. They are also advancing treatments for liver cirrhosis complications.

The Phase 2b trial marks a significant step in addressing the unmet medical needs of long COVID patients, with the Advisory Board’s expertise being crucial to its success.