BioVie Secures FDA Approval for Bezisterim Long COVID Study
BioVie Receives FDA Authorization for Phase 2 Trial
BioVie Inc. (NASDAQ: BIVI) is excited to share that it has successfully obtained U.S. Food and Drug Administration (FDA) authorization for its Investigational New Drug (IND) application to conduct a Phase 2 trial. This trial will assess the efficacy of bezisterim, a promising candidate aimed at alleviating neurological symptoms associated with long COVID.
Milestone Achievement Ahead of Schedule
Achieving this key milestone can potentially lead to an additional $12.6 million in grant funding from the U.S. Department of Defense (DOD). This financial backing will support the forthcoming trial, which signifies a leap forward in understanding and addressing long COVID.
Growing Recognition of Long COVID
Recent surveys indicate that about 5.5% of adults in the U.S. are grappling with long COVID, with approximately 3.6 million individuals reporting significant lifestyle changes due to ongoing symptoms. Long COVID is characterized by a variety of symptoms that persist long after the initial COVID-19 infection has resolved.
Bezisterim: A Novel Treatment Approach
Bezisterim is being explored for its anti-inflammatory properties that may help mitigate the neurocognitive issues frequently seen in long COVID patients. The planned study intends to enroll around 200 participants, focusing on the safety and tolerability of bezisterim over a three-month treatment period while evaluating its potential to reduce cognitive dysfunction and fatigue.
Understanding Long COVID
Long COVID refers to lingering symptoms, such as cognitive dysfunction, fatigue, and debilitating neurological effects, that can last for several months. Chronic inflammation may play a significant role in its persistence, with researchers suggesting that inflammation could lead to sustained symptoms like “brain fog.”
Department of Defense Grant Specifics
The DOD has committed initial funding of $499,200 for early planning, with the promise of an additional $12.6 million upon meeting subsequent milestones. This grant will facilitate pivotal steps crucial for the upcoming clinical trial.
Bezisterim’s Broader Implications
Bezisterim, also known as NE3107, is not only aimed at treating long COVID but is undergoing investigations for other severe conditions, including Alzheimer’s and Parkinson’s diseases. Previous studies have shown encouraging results, suggesting that it can effectively improve cognition and reduce neurological symptoms in affected patients.
BioVie’s Commitment to Innovation
BioVie Inc. stands at the forefront of developing advanced therapies for challenging neurological and liver diseases. With a strategic focus on reducing neuroinflammation, their therapies represent a new horizon for patients coping with serious health challenges.
Frequently Asked Questions
What is the purpose of the Phase 2 trial for bezisterim?
The trial aims to evaluate the safety and effectiveness of bezisterim in reducing neurocognitive symptoms in long COVID patients.
How does bezisterim work?
Bezisterim functions as an anti-inflammatory agent that may help modulate inflammation linked to long COVID symptoms.
What are the expected outcomes of the trial?
The trial seeks to determine the tolerability, safety, and potential benefits of bezisterim over a three-month period.
Who is eligible to participate in the trial?
Approximately 200 adults experiencing symptoms of long COVID will be recruited for this multicenter trial.
What is BioVie’s broader mission?
BioVie is dedicated to developing innovative therapies that address neurological disorders and liver diseases, enhancing patient quality of life.
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