CARSON CITY, Nev. - BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has authorized its Investigational New Drug (IND) application for bezisterim, a treatment aimed at neurological symptoms of long COVID. This authorization enables BioVie to proceed with a Phase 2 trial, which is supported by a U.S. Department of Defense (DOD) grant that could total $12.6 million upon meeting certain milestones.
The Phase 2 study is designed as a randomized, placebo-controlled, multicenter trial involving approximately 200 patients. The trial will assess the safety, tolerability, and efficacy of bezisterim over a 3-month treatment period, focusing on reducing neurocognitive symptoms associated with long COVID, a condition characterized by persistent symptoms following an acute SARS-CoV-2 infection.
BioVie's President and CEO, Cuong Do, expressed optimism about the potential of bezisterim to address the inflammation believed to be driving long COVID symptoms, including cognitive dysfunction and fatigue. Bezisterim, which can cross the blood-brain barrier, has shown promise in modulating inflammation through the activation of NF-kB, a protein complex that controls the transcription of DNA.
The Centers for Disease Control and Prevention (CDC) has recently reported that approximately 5.5% of U.S. adults are currently affected by long COVID, with an estimated 3.6 million people modifying their activities due to the illness. With no effective treatments currently available, the economic impact, including lost quality of life and increased medical costs, is substantial.
In addition to the planned long COVID trial, bezisterim is being investigated for its potential in treating other neurological disorders such as Alzheimer's and Parkinson's diseases. Past studies have shown bezisterim's efficacy in improving cognition and biomarker levels in Alzheimer's patients, and significant improvements in Parkinson's disease symptoms when used in combination with levodopa.
The DOD's endorsement and financial support for the study underscore the urgency in addressing the challenges posed by long COVID. However, the views expressed in this press release are those of BioVie and do not necessarily reflect the official policy or position of the DOD.
This announcement is based on a press release statement issued by BioVie Inc. and provides an overview of the company's next steps in exploring potential treatments for long COVID.
In other recent news, BioVie Inc. has made significant strides in its clinical trials and corporate operations. The biopharmaceutical company presented new clinical data on its drug candidate, bezisterim, at the 11th Aging Research and Drug Discovery (NASDAQ:WBD) Meeting. The findings suggest that bezisterim may influence the biological aging process and chronic inflammation associated with aging-related diseases. The drug is being investigated for its potential in treating Alzheimer's and Parkinson's disease, with promising results from Phase 2 and Phase 3 studies.
BioVie Inc. has also regained compliance with Nasdaq's minimum bid price requirement, a significant step towards stabilizing its market position. The company completed a 1-for-10 reverse stock split of its Class A common stock, a strategic move approved by shareholders to consolidate shares. These are recent developments, highlighting the company's commitment to maintaining its marketability and compliance with stock exchange requirements.
In further news, BioVie announced the resignation of director Steve Gorlin, a notable change in the firm's leadership structure. The company continues to make substantial progress in its Phase 2a trial of bezisterim for Parkinson's Disease treatment, showing improvements in both motor and non-motor symptoms compared to a placebo. With these developments, BioVie continues to demonstrate its commitment to pharmaceutical innovation and corporate evolution.
InvestingPro Insights
As BioVie Inc. (NASDAQ: BIVI) embarks on the Phase 2 trial for its promising treatment of long COVID symptoms, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, BioVie currently holds a market capitalization of 16.99 million USD, indicating its size within the biopharmaceutical sector. Despite the challenges faced in profitability, with a reported operating loss of 38.37 million USD in the last twelve months as of Q3 2024, BioVie's strategic moves, such as the recent FDA IND authorization, play a crucial role in potential future valuations.
InvestingPro Tips highlight a critical aspect of BioVie's financial position: the company holds more cash than debt, which could provide a buffer as it funds its clinical trials. Additionally, BioVie's liquid assets exceed its short-term obligations, suggesting the company is in a position to manage its immediate financial responsibilities. These insights are particularly relevant as the company navigates the capital-intensive phase of clinical trials.
However, the InvestingPro Tips also underscore some concerns; analysts do not expect BioVie to be profitable this year, and the stock has experienced a significant decline over the past year, with a price total return of -91.0%. Such metrics could reflect market skepticism about the company's near-term revenue prospects, despite the potential of its treatments. Investors may find additional context in the 9 InvestingPro Tips available on the platform, which provide a deeper analysis of BioVie's financial health and market performance.
For those interested in a comprehensive investment analysis, additional InvestingPro Tips for BioVie can be found at https://www.investing.com/pro/BIVI.
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