CARSON CITY, Nev. - BioVie Inc. (NASDAQ: BIVI), a clinical-stage biopharmaceutical company, has received approval from the U.S. Army Medical Research and Development Command's Office of Human Research Oversight (OHRO) to proceed with a Phase 2 clinical trial of bezisterim, an investigational drug for the treatment of neurological symptoms associated with long COVID. This approval marks the final scientific review needed for BioVie to access an additional $12.6 million in grant funding from the U.S. Department of Defense (DOD).
The Food and Drug Administration (FDA) had previously given the green light for the study in August 2024, deeming it safe to proceed. The Phase 2 trial, expected to begin by early 2025, will be a randomized, placebo-controlled, multicenter study involving around 200 patients. The trial aims to assess the safety, tolerability, and efficacy of bezisterim over a three-month treatment period.
Long COVID is a condition characterized by persistent symptoms of COVID-19, such as cognitive dysfunction and fatigue, lasting for three months or more. According to the Centers for Disease Control, over 17 million adults in the United States have experienced or are currently experiencing long COVID. To date, no effective treatments have been established for this condition.
Bezisterim is an orally bioavailable drug that can cross the blood-brain barrier and has shown potential in modulating inflammation. Chronic inflammation and blood-brain-barrier dysfunction are believed to play a role in the persistence of long COVID symptoms. The drug is also under investigation for other neurodegenerative diseases, including Alzheimer's and Parkinson's.
The DOD grant, endorsed by the Assistant Secretary of Defense for Health Affairs, initially allocated $499,200 for the planning phase, with the option to receive the additional funds for the clinical trial upon meeting certain milestones.
BioVie's research into bezisterim aligns with the broader medical community's efforts to address the long-term effects of COVID-19. The company is also developing therapies for advanced liver disease and other neurological disorders.
This article is based on a press release statement from BioVie Inc. and reflects the company's current plans and expectations regarding their clinical trials and funding.
In other recent news, BioVie Inc. has secured FDA authorization for its Investigational New Drug application for bezisterim, a potential treatment for long COVID symptoms. This approval allows BioVie to proceed with a Phase 2 trial, backed by a Department of Defense grant that could amount to $12.6 million upon reaching certain milestones. The trial aims to evaluate the safety, tolerability, and efficacy of bezisterim in managing neurocognitive symptoms associated with long COVID.
BioVie has also presented new clinical data on bezisterim at the 11th Aging Research and Drug Discovery (NASDAQ:WBD) Meeting, indicating the drug's potential influence on the biological aging process and chronic inflammation related to aging-related diseases. The drug is being studied for its potential in treating Alzheimer's and Parkinson's diseases, with promising results from Phase 2 and Phase 3 studies.
Furthermore, the biopharmaceutical company has regained compliance with Nasdaq's minimum bid price requirement, following a 1-for-10 reverse stock split of its Class A common stock. This strategic move was approved by shareholders to consolidate shares. In a significant change in the firm's leadership structure, BioVie announced the resignation of director Steve Gorlin. Despite this, the company continues to make substantial progress in its Phase 2a trial of bezisterim for Parkinson's Disease treatment, demonstrating improvements in both motor and non-motor symptoms compared to a placebo. These are all recent developments in the company's ongoing commitment to pharmaceutical innovation and corporate evolution.
InvestingPro Insights
As BioVie Inc. (NASDAQ: BIVI) gears up for its Phase 2 clinical trial with the backing of the U.S. Department of Defense, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, BioVie currently holds a market capitalization of $19.31 million, indicating the size of the company in the biopharmaceutical industry. Despite challenges, the company has experienced a noteworthy return over the last week, with a 24.41% increase in its stock price, showcasing a potential rebound or positive market reaction to recent developments.
However, it's important to note that BioVie's gross profit margins have been weak, and analysts do not expect the company to be profitable this year. This is reflected in the company's negative P/E ratio of -0.33, suggesting that investors are currently not expecting earnings growth. Additionally, BioVie's return on assets over the last twelve months has been significantly negative at -94.32%, indicating that the company has not been generating profit from its assets efficiently.
On a more positive note, one InvestingPro Tip highlights that BioVie's liquid assets exceed its short-term obligations, which could provide some financial stability and flexibility as it proceeds with its clinical trials. Furthermore, BioVie holds more cash than debt on its balance sheet, which is a reassuring sign for investors concerned about the company's debt levels.
For readers interested in a deeper analysis, there are additional InvestingPro Tips available, offering a comprehensive view of BioVie's financials, stock performance, and market position. To explore these insights, visit: https://www.investing.com/pro/BIVI
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