BioVie Inc. (NASDAQ: BIVI) is set to advance its drug candidate, bezisterim, into a Phase 2 clinical trial for the treatment of Long COVID, a condition affecting millions with persistent symptoms following a SARS-CoV-2 infection. The design of this trial will be presented at the Demystifying Long COVID International Conference in Barcelona, Spain.
The planned Phase 2 study is structured as a double-blind, randomized (1:1), placebo-controlled, multicenter trial. It aims to enroll approximately 200 patients to assess the safety, tolerability, and potential efficacy of bezisterim over a three-month treatment period. The primary focus will be on reducing the neurocognitive symptoms associated with Long COVID.
Trial Design and Objectives
The study's primary objective is to evaluate the impact of bezisterim on the neurocognitive symptoms that commonly plague Long COVID patients, including brain fog, fatigue, and other neurological issues. The trial will adhere to rigorous scientific standards, with data collection and analysis designed to provide robust evidence of the drug's effects.
Penelope Markham, Ph.D, Senior Vice President and Program Lead, Long COVID, BioVie Inc., will present the poster.
Funding and Support
This critical research is fully funded by a $13,137,150 grant from the U.S. Department of Defense (DOD), highlighting the urgency and importance of finding effective treatments for Long COVID. The award, granted through the Peer Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113, underscores the commitment to addressing the long-term health consequences of the COVID-19 pandemic.
The Unmet Need in Long COVID Treatment
Long COVID is characterized by the persistence of COVID-19 symptoms for three months or more after the initial infection. Common symptoms include loss of smell and taste, extreme fatigue, and cognitive dysfunction. Recent data suggests that a significant percentage of adults in the United States experience Long COVID, leading to substantial economic impact due to loss in quality of life, earnings, and increased medical costs. Currently, there are no proven effective pharmacological therapies for Long COVID, making the development of treatments like bezisterim crucial.
Bezisterim's Mechanism of Action
Bezisterim (NE3107) is designed to inhibit inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-kB, reducing neuroinflammation and insulin resistance, which are implicated in neurodegenerative disorders and Long COVID. By targeting these key pathways, bezisterim aims to alleviate the neurological symptoms experienced by Long COVID patients.
