BIOXYTRAN, INC. announced that in vitro testing at the Foundation for Neglected Disease Research (FNDR) in Bangalore India, showed that leading drug candidate ProLectin-M (PL-M) showed a significant reduction of viral load in influenza (H1N1) and in human Respiratory Syncytial Virus (RSV). The newest in vitro results, completed in early February 2023, are similar in nature to the SARS-CoV-2 test results that ultimately led to the successful completion of 2 clinical trials. The positive data and the non-toxic nature of the molecule justifies an IND filing to proceed to phase 2 human clinical trials.

These in vitro test results add to the body of evidence that PL-M has the potential to be a broad-spectrum antiviral useful in the treatment of Upper Respiratory Infections (“URI”) and as a potential treatment of populations infected by a “tripledemic” recently warned of by public health officials: that is peak infections, at the same time, of RSV, Influenza, and COVID-19. In December 2022 a wave of COVID-19, RSV, and Influenza infections hit all at once putting pressure on the hospital systems by maxing out the number of beds available. This pressure on the hospital systems had no relieve valve because there are no triage like treatments for standard risk patients.

Influenza has been infecting people worldwide since the 1500's and the only way to control influenza is through the use of personal protective measures and frequent handwashing. There are a number of antiviral treatment options like oseltamivir phosphate (Tamiflu®) which was the positive control in study, but these antivirals are designed to inhibit replication and must be taken within two days of symptoms. PL-M has a different mechanism of action as an entry inhibitor, and is designed to stop infectivity and spread of the disease throughout the body. RSV is a highly contagious virus that primarily effects babies and older adults with underlying medical conditions and can lead to serious infections, including bronchiolitis, and pneumonia.

There are over 57,000 hospitalizations, 500,000 emergency room visits and 1.5 million outpatient clinic visits among children less than 5 years of age that contract RSV. In adults there are 177,00 hospitalizations and 14,000 deaths annually. There are no known treatments except the management of the symptoms. Drug developers are working on vaccines and antiviral treatments.

With this excellent in vitro data in hand from influenza and RSV, the Company anticipates it will add additional treatment arms to its COVID-19 studies. About ProLectin-M: ProLectin-M is an oral galectin antagonist that prevents the entry of the SARS-CoV-2 virus into human cells. In recent clinical trials the drug achieved a 100% responders rate of negative PCR tests by day 7. In 3 days, the drug achieved an 88% responders rate of negative PCR tests.

The treated population experienced no viral rebounds during the 14-day observation period. The company is preparing for a phase 3 clinical trial in order to seek regulatory approval.