The completed Phase 2 clinical study was a randomized, double-blind, placebo-controlled, dose-optimization trial evaluating orally administered ProLectin-M in subjects with acute viral infection. The study enrolled 38 subjects, all of whom completed the study. Subjects were randomized to receive one of three ProLectin-M dose levels or a matching placebo, administered over a seven-day treatment period.

Viral shedding was assessed using RT-PCR analysis of nasopharyngeal swabs collected at predefined timepoints, with viral clearance defined as non-detection of viral RNA below established PCR thresholds.

The study design, endpoints, and duration confirmed Bioxytran’s earlier randomized, placebo-controlled Phase 2 trial, which demonstrated statistically significant reductions in viral load by Day 7, early clearance as soon as Day 3, and no observed viral rebounds during a 14-day post-treatment observation period. The current trial further refined dose selection of four tablets per day and evaluated the reproducibility of rapid viral clearance using the same core virologic assessment methodology.

Topline Viral Clearance Results

Following database lock and unblinding, treatment-wise analyses demonstrated the following outcomes:

Complete elimination of viral load in 100% of treated subjects by Day 7, compared to the placebo group (p = .001)

No viral rebounds observed in the treated population during the 14-day post-treatment observation period

These results indicate rapid and sustained viral clearance in subjects treated with ProLectin-M.

Viral Clearance Timing (All Subjects)

Across the full study population:

Day 3: 1 of 38 subjects demonstrated non-detection of viral shedding

Day 5: 16 of 38 subjects demonstrated non-detection of viral shedding

Day 7: 38 of 38 subjects demonstrated non-detection of viral shedding

The study was designed to evaluate viral clearance kinetics and inform dose selection for future late-stage clinical development.

“The study design of seven days reflects real-world applications for treating acute viral diseases, with the objective of demonstrating a statistically meaningful reduction in viral load by Day 7,” said Dr. Leslie Ajayi, Chief Medical Officer of Bioxytran. “The results demonstrate that viral clearance occurred more rapidly than anticipated, with a significant proportion of treated subjects achieving viral non-detection by Day 3 and complete clearance by Day 7.”

“What continues to distinguish ProLectin-M as a broad-range antiviral drug is its novel mechanism of action,” Dr. Platt continued. “Rather than targeting viral replication inside the cell, our galectin antagonist is designed to interfere with viral entry at the cell surface. This extracellular approach may reduce reliance on immune activation and represents a fundamentally different strategy in antiviral therapy. We believe these results further support the potential of carbohydrate-based therapeutics and the emerging field of Glycovirology.”

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