BioVie Gains Scientific Approvals for $12.6M Grant to Start Phase 2 Bezisterim Trial for Long COVID

BioVie Inc., a clinical-stage biopharmaceutical company focusing on treatments for neurological, neurodegenerative disorders, and advanced liver disease, has received approval from the U.S. Army Medical Research and Development Command's Office of Human Research Oversight (OHRO) to proceed with a study involving the drug bezisterim for treating neurological symptoms associated with long COVID. This approval is a crucial milestone, enabling BioVie to access $12.6 million in funding from the U.S. Department of Defense (DOD) and initiate Phase 2 clinical trials.

The planned Phase 2 study is a randomized, placebo-controlled trial involving approximately 200 patients. It aims to assess the safety and efficacy of bezisterim over a three-month treatment period in reducing neurocognitive symptoms linked to long COVID.

Long COVID, a condition where COVID-19 symptoms persist for an extended period, typically three months or more, affects millions of adults in the U.S. Symptoms include cognitive dysfunction and fatigue, severely impacting quality of life. Chronic inflammation is believed to be a key factor contributing to long COVID symptoms, particularly in cases of "brain fog," which involves sustained systemic inflammation and blood-brain-barrier dysfunction. Bezisterim, known for its ability to cross the blood-brain barrier and modulate inflammation by activating NF-kB, offers a novel approach to treating these symptoms.

The Department of Defense has awarded BioVie a total of $499,200 for the planning phase, with the potential for an additional $12.6 million to support the clinical trial, contingent on the successful completion of planning milestones. This funding is part of the Peer-Reviewed Medical Research Program (PRMRP).

Long COVID remains a significant public health issue, with an estimated 17 million adults in the U.S. experiencing symptoms such as fatigue and cognitive impairments. The economic impact of long COVID, in terms of lost quality of life, earnings, and medical costs, is estimated at $3.7 trillion. Despite extensive research, no effective pharmacological or non-pharmacological treatments for long COVID have been identified to date. Elevated levels of inflammatory proteins and immune regulation markers in long COVID patients support the hypothesis of chronic inflammation being a primary cause of persistent symptoms.

Bezisterim, an orally available drug that permeates the blood-brain barrier and acts as an insulin-sensitizer with anti-inflammatory properties, is being studied for its potential to alleviate symptoms of long COVID. The drug is also under investigation for treating Alzheimer's disease (AD) and Parkinson's disease (PD), with promising Phase 3 and Phase 2 trial results, respectively. In AD patients, bezisterim has shown improvements in cognition and biomarker levels, while in PD patients, it has demonstrated significant motor control improvements when used in combination with levodopa.

BioVie Inc. continues to advance its pipeline of innovative therapies aimed at treating neurological and neurodegenerative disorders. The company's lead drug candidate, bezisterim, targets neuroinflammation and insulin resistance, key factors in conditions like AD and PD. Additionally, BioVie is developing BIV201, an Orphan drug candidate for treating ascites due to chronic liver cirrhosis, which has received FDA Fast Track status.

With the recent OHRO approval, BioVie is poised to begin Phase 2 trials of bezisterim for long COVID by early 2025, potentially offering a new therapeutic option for this debilitating condition.