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BioVie receives $13.1 million DOD grant for long COVID trial

EditorBrando Bricchi
Published 05/01/2024, 02:36 AM

CARSON CITY, Nev. - BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, has been awarded a grant of up to $13.1 million from the U.S. Department of Defense (DOD) to fund a Phase 2b clinical trial of bezisterim, an anti-inflammatory and insulin-sensitizing drug. The trial is designed to assess the treatment of neurological symptoms associated with long COVID, a condition characterized by persistent symptoms following a COVID-19 infection.

The grant, provided through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs, includes an initial $499,200 for the planning phase with an option to fund the $12.6 million clinical trial after planning concludes. The trial is expected to begin by early 2025 and will evaluate the safety, tolerability, and efficacy of bezisterim in approximately 200 patients over a three-month treatment period.

Long COVID affects over 17 million adults in the United States, with symptoms such as fatigue, cognitive dysfunction, and sleep disturbances. The economic impact of the condition is significant, with estimated costs of $3.7 trillion due to loss in quality of life, earnings, and increased medical expenses. Currently, there are no proven therapies for treating long COVID.

Bezisterim's ability to permeate the blood-brain barrier and modulate inflammation through the activation of NF-kB makes it a promising candidate for addressing the underlying causes of long COVID symptoms. The drug is also being investigated for its potential in treating Alzheimer's disease and Parkinson's disease.

BioVie's President & CEO, Cuong Do, expressed optimism about the trial, citing the alignment of bezisterim's mechanism of action with the emerging evidence for the pathophysiology of long COVID. Dr. Michael Peluso, who leads a Long COVID clinical trials program at the University of California, San Francisco, also welcomed the funding and the opportunity to explore the drug's potential further.

This news is based on a press release statement from BioVie Inc. and represents a significant step in the search for effective treatments for long COVID and related neurological conditions.

InvestingPro Insights

As BioVie Inc. (NASDAQ: BIVI) advances its clinical trials with the recent grant from the DOD, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, BioVie has a market capitalization of $26.62 million, reflecting the scale of the company within the biopharmaceutical sector. Despite the promising clinical developments, the company's financial metrics indicate challenges. With an adjusted P/E ratio for the last twelve months as of Q2 2024 at -0.62, BioVie's earnings are currently negative, which aligns with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year.

Furthermore, the stock has experienced a significant downturn, with a 1-year price total return as of 2024 at -93.93%. This is corroborated by multiple InvestingPro Tips highlighting the substantial price decline over the past year, including the last three and six months. These metrics suggest that while the clinical potential of bezisterim is noteworthy, the market has reacted to BioVie's current financial standing and future profitability concerns.

Investors considering BioVie Inc. should note the company's advantageous cash position, as it holds more cash than debt on its balance sheet, an InvestingPro Tip that may offer some solace amidst the stock's recent performance. However, the lack of dividends, as indicated by another InvestingPro Tip, might be a factor for those seeking income-generating investments.

For those looking for a more comprehensive analysis, there are additional InvestingPro Tips available on the platform. To explore these insights and make more informed decisions, investors can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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