Bioxytran, Inc. has announced positive Phase 2 clinical results for its ProLectin-M drug, demonstrating complete viral clearance in 100% of patients with acute viral infections by the seventh day of treatment.
The clinical study was a randomized, double-blind, placebo-controlled dose-optimization trial, involving 38 participants who were administered ProLectin-M in varied doses over seven days. The results showed statistically significant reductions in viral load compared to the placebo group, with a p-value of .001.
Key findings revealed that while complete viral clearance was observed by Day 7 in all treated subjects, some level of viral non-detection was already measurable by Day 3, with one subject exhibiting non-detection, and by Day 5, this number increased to 16 subjects. Importantly, no viral rebounds were detected during a subsequent 14-day post-treatment observation period.
These results underscore the rapid and effective viral clearance properties of ProLectin-M. Dr. Leslie Ajayi, Chief Medical Officer of Bioxytran, noted that the trial aimed to reflect real-world treatment timelines and succeeded in demonstrating a statistically meaningful reduction in viral load within seven days.
The mechanism of action behind ProLectin-M involves the interference with viral entry at the cell surface, distinguishing it as a novel antiviral approach that reduces reliance on immune system activation. This extracellular intervention could represent a fundamentally different strategy in antiviral therapy, potentially broadening the scope of its application to various viral infections.
Following these promising results, Bioxytran plans to engage in further regulatory discussions to support late-stage clinical trials and explore the effectiveness of ProLectin-M across a broader range of viral indications.
The company remains committed to advancing its novel carbohydrate-based therapeutics in addressing significant unmet medical needs within the field of virology.