BOSTON, MASSACHUSETTS, Aug. 08, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced the initiation of a clinical trial to treat Mild to Moderate COVID-19 patients. The trial’s objective is to provide guidance for a 408 patient Phase III trial.
Based on the success of Bioxytran’s Phase 2 trial in mild to moderate COVID-19 patients which achieved a 100% response rate by day 7 versus 6% in placebo the Central Drugs Standard Control Organization (CDSCO) in India approved the clinical trial protocol.
The Company is initiating the first stage of its registrational trial which is a dose optimization study that will evaluate 3 different dosage levels against a matching placebo arm in a 5-day trial. The primary endpoints are time weighted average change in SARS-CoV-2 viral load and time to non-detection of viral shedding in outpatient swabs at various time intervals. Inclusion criteria allows for the recruitment of patients at high risk for progression to severe COVID-19 or patients with a Ct value less than 25. The next stage is large randomized double-blind placebo-controlled Phase 3 study with 408 patients looking to assess a statistically significant increase in responders rate at day 5 over placebo.
“The initiation of this clinical trial is an important milestone for the pivotal COVID-19 program as well as the advancement in our pursuit of taming upper respiratory tract infections,” said Dr Leslie Ajayi, Bioxytran Chief Medical Officer. “This COVID-19 trial is simply a case study designed to showcase the platform potential of our drug. We are in the endemic phase of the pandemic and it’s just a matter of time before the next variant causes widespread illness. Right now there is a hot spot in the United Kingdom due to a rise in the EG.5.1 variant. The quick spreading nature of this variant is probably linked to the immune evasion from the SARS-CoV-2 vaccines and therapies that are waning in effect. This leaves a large unmet medical need for standard risk patients. We see the incredible potential of this glycovirology platform and recognize its ability to swiftly neutralize viruses thereby limiting contagion. If approved the chewable tablets would represent our first line of defense against the next pandemic and be deployed to these hot spots when they flare up.”
About Bioxytran, Inc.
Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at www.bioxytraninc.com
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