Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone required for Company to obtain bulk of $13.1 million grant funding
Company expects Phase 2 trial to start by early 2025
CARSON CITY, Nev., Sept. 16, 2024 (GLOBE NEWSWIRE) — BioVie Inc., a clinical-stage company focused on innovative drug therapies for neurological, neurodegenerative disorders, and advanced liver disease, has announced the approval from the U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO) for BioVie’s plan to evaluate bezisterim for treating neurological symptoms associated with long COVID. The FDA had previously given the go-ahead for the study in August 2024. OHRO’s approval represents the final scientific review needed for BioVie to secure an additional $12.6 million in grant funding from the U.S. Department of Defense (DOD) to initiate Phase 2 testing in long COVID.
New Phase 2 Trial Exploration
The upcoming Phase 2 study will be a randomized (1:1), placebo-controlled, multicenter trial involving roughly 200 patients. The aim is to assess the safety, tolerability, and potential effectiveness of a 3-month treatment with bezisterim in alleviating the neurocognitive symptoms associated with long COVID.
The Persistence of Long COVID
Long COVID is a condition where the symptoms of COVID-19 persist for an extended period, typically three months or more. Surpassing 17 million adults in the U.S., according to recent data from the Centers for Disease Control, have been affected by or are currently battling long COVID. Symptoms range from cognitive dysfunction to fatigue, severely impacting individuals. Despite extensive research, no treatment has yet proven to be efficacious. Researchers speculate that chronic inflammation plays a crucial role in the endurance of long COVID symptoms, with sustained systemic inflammation and persistent blood-brain-barrier dysfunction being identified as key physiological factors in individuals experiencing “brain fog.”
Insight into Department of Defense Grant
Under the Department of Defense Award, the Assistant Secretary of Defense for Health Affairs has approved a sum of $499,200 for the planning phase, with the provision for an additional $12.6 million upon meeting certain milestones to kickstart the clinical trial through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. The views and opinions expressed are solely those of the author and may not necessarily reflect the stance of the Assistant Secretary of Defense for Health Affairs or the Department of Defense.
Understanding Long COVID Impact
Long COVID continues to impact millions of individuals, with symptoms ranging from loss of smell and taste to extreme fatigue and cognitive impairment, vastly reducing the quality of life for sufferers. The economic toll of long COVID is estimated to be a staggering $3.7 trillion, showcasing the urgency in finding effective treatments. Chronic inflammation remains a leading hypothesis in explaining the persistence of long COVID symptoms, and drug treatments targeting inflammation and blood-brain-barrier function may hold promise in managing the neurological manifestations of the condition.
Insights into Bezisterim
Bezisterim (NE3107) stands out as an orally bioavailable, blood-brain-barrier-permeable, insulin-sensitizing, and anti-inflammatory agent. With a low risk of drug interactions and no immunosuppressive effects, bezisterim shows potential in alleviating long COVID symptoms, notably fatigue and cognitive dysfunction. The modulation of NFkB activation by bezisterim is key in its anti-inflammatory action, showing promise as a novel treatment approach.
Bezisterim’s impact extends beyond long COVID, with investigations ongoing for Alzheimer’s disease and Parkinson’s disease. Efficacy data from studies on Alzheimer’s and Parkinson’s patients have shown positive outcomes, hinting at the broader therapeutic potential of bezisterim.
In conclusion, BioVie’s progress in obtaining the necessary approvals and funding to launch a Phase 2 trial for long COVID marks a significant milestone in the pursuit of effective treatments for this debilitating condition. The exploration of bezisterim’s therapeutic potential in addressing neurological symptoms associated with long COVID opens new possibilities in the field of drug development and disease management.
BioVie Inc. Phase 3 Clinical Testing for Ascites Due to Chronic Liver Cirrhosis
Putting science under the commercial microscope once again, BioVie Inc. is embarking on a transformative journey through the design of Phase 3 clinical trials for BIV201. This novel treatment targets ascites due to chronic liver cirrhosis, beckoning a pivotal chapter in the company’s timeline. Already approved in the U.S. and approximately 40 countries for related complications of advanced liver cirrhosis, BIV201 has gained a well-earned reputation in the medical realm.
Looking Back
Delving into history’s annals, one recalls the arduous path traversed by BioVie Inc. as it navigated the regulatory labyrinth to secure approvals in various nations. The sweat and toil of the company’s journey have culminated in this landmark moment of Phase 3 clinical testing.
A Proactive Stance
Embodying a proactive ethos, BioVie Inc. takes measured steps towards advancing medical science. The firm’s commitment to robust research and development shines through its pursuit of cutting-edge treatments for complex conditions such as ascites in chronic liver cirrhosis.
Navigating Challenges
Braving the unknown, BioVie Inc. confronts a series of challenges in the realms of clinical trials, regulatory approvals, and market acceptance. The company’s ability to overcome these hurdles symbolizes its resilience and determination in the face of adversity.
Towards a Brighter Future
As the sun sets on one phase of testing, another dawn beckons for BioVie Inc. The company’s unwavering focus on innovation and patient care paves the way for a brighter future, where groundbreaking treatments like BIV201 may offer hope to those in need.