Business
BioVie Secures All Scientific Approvals Needed to Receive Additional $12.6 Million of Grant Funding to Launch Planned Phase 2 Trial to Evaluate Bezisterim in Long COVID
Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone needed for Company to
About this update from Biovie Inc.
[{"type":"text","content":"Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone needed for Company to receivebulk of $13.1 million grant funding Company anticipates Phase 2 trial to commence by early 2025 CARSON CITY, Nev., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the U.S. Army Medical Research and Development Command, Office of Human Research Oversight, (OHRO) has approved BioVie’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. FDA had previously reviewed and approved the study as Safe to Proceed in August 2024. Approval from OHRO is the last scientific review milestone needed for the Company to receive the additional $12.6 million in grant funding from the U.S. Department of Defense (DOD) and initiate Phase 2 testing in long COVID. The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with long COVID. Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that more than 17 million adults in the United States currently or previously had long COVID.1 Symptoms include cognitive dysfunction and fatigue and are debilitating. No therapies have proven effective for treatment to date. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting a suspected underlying cause of long COVID symptoms. Terms of the De...