Bioxytran’s Oral Antiviral Drug to Enter Dose Optimization Clinical Trial for COVID-19

First Medicinal chemistry of an antiviral drug made of sugars

BOSTON, MASSACHUSETTS, Feb. 21, 2024 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT), (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat viral diseases, announced that the first patients have been treated with ProLectin-M in its dose optimization trial. ProLectin-M is intended to become a first line treatment for standard risk COVID-19 patients, but based on the broad-spectrum in vitro discovery could easily expand to upper respiratory tract infections. Following this dose optimization trial, Bioxytran intends to use the trial data to inform the design of the Phase 3 registrational trial in India, while also adhering to the FDA’s request for additional data.

The multi-center clinical trial in India will be a randomized double-blind placebo-controlled trial and is set to enroll 40 patients. ProLectin-M has previously established efficacy in two, previously conducted, peer-reviewed clinical trials with a 100% responders rate in both trials and p-values of .05 and .001. In the past decade only one other antiviral has, to our knowledge, achieved a similar preliminary efficacy profile. The Company has already established the non-toxic profile of its galectin antagonists. Official additional studies are anticipated and planned in the United States.

“After we complete the dose optimization trial, the next regulatory milestone is a registrational trial,” said Dr. Leslie Ajayi, Bioxytran’s medical director. “We are on the cusp of completing a clinical trial of standard risk patient that contracted COVID-19. Completing our registrational trial will position our oral galectin antagonist as the first line therapy for the single largest respiratory viral disease indication in the world. Should we achieve approval in COVID-19, we will embark on an expansion plan that will include influenza and Respiratory Syncytial Virus (RSV). We have reason to believe that our galectin antagonist is a broad spectrum antiviral capable of neutralizing a number of viruses capable of upper respiratory tract infections. We are advancing the field of Glycovirology and working toward bringing to market the potential first broad spectrum antiviral capable of neutralizing a number of viruses without changing the formulation and theoretically resistant to viral mutations.”