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BioVie Announces FDA Authorization of Investigational New Drug Application for Phase 2 Trial to Evaluate Bezisterim in Long COVID
Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated
About this update from Biovie Inc.
[{"type":"text","content":"Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated with long COVID Key milestone reached ahead of schedule, with BioVie on track to receive additional $12.6 million of award from the U.S. Department of Defense and initiate the Phase 2 trial Recent Centers for Disease Control and Prevention survey estimated over 5% of U.S. adults currently have long COVID, and ~3.6 million people reported significantly modifying their activities because of illness1 CARSON CITY, Nev., Sept. 03, 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. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (“IND”) application to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. Receipt of this FDA authorization puts the Company ahead of schedule and on track to receive an additional $12.6 million in grant funding from the U.S. Department of Defense (“DOD”) and initiate its Phase 2 trial. “We are delighted to announce that the FDA has authorized our IND application for bezisterim, allowing us to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID,” said Cuong Do, BioVie’s President and CEO. “A growing body of evidence points to inflammation as a key driver of long COVID, and we believe that bezisterim has shown promise in addressing these underlying mechanisms. This is a significant milestone that brings us closer to exploring how bezisterim could help patients with this debilitating condition.” The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety and tolerability of 3 months of treatment with bezisterim and the potential ability 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...