Bioxytran says its experimental oral antiviral ProLectin-M delivered statistically significant early viral clearance in hospitalized patients with mild to moderate COVID-19, marking what the company calls a potential breakthrough for a new class of carbohydrate-based therapeutics.

 

In a randomized, double-blind, placebo-controlled Phase 1b/2a study, the highest tested dose of ProLectin-M — 16,800 mg per day — achieved non-detectable viral shedding by Day 5 in 90% of participants. That compared with 20% in the placebo group, a difference that reached statistical significance.

 

The 39-patient trial, conducted in India among individuals with RT-PCR-confirmed SARS-CoV-2 infection, evaluated three dosing levels of ProLectin-M plus standard of care against placebo plus standard of care over five days.

 

While all patients across study arms cleared the virus by Day 7 — consistent with the natural course of mild-to-moderate COVID-19 — the company says the Day-5 separation highlights ProLectin-M’s potential to accelerate viral resolution.

 

Clinical improvement tracked closely with viral clearance. By Day 5, 90% of patients in the highest-dose cohort achieved at least a two-point improvement on the WHO Ordinal Scale, compared with 20% in the placebo arm and 20% to 40% in lower-dose groups. All participants improved by Day 7.

 

“We believe an oral, well-tolerated antiviral with a differentiated mechanism could address important gaps in current treatment approaches, particularly in early-stage respiratory infections.” said Dr. Leslie Ajayi, Bioxytran’s Chief Medical Officer. 

 

“Our clinical data suggests ProLectin-M demonstrated earlier reductions in viral shedding compared with placebo with a favorable safety profile, and these findings support further evaluation of ProLectin-M in larger, well-controlled studies to assess its potential role as a first-line therapy.”

 

Cycle threshold (Ct) values — a proxy for viral load — rose across all groups over time, signaling declining viral burden. However, numerically earlier Ct increases were observed in the highest-dose group as early as Day 3, reinforcing the Day-5 antiviral signal.

 

Safety data showed no serious adverse events, no treatment-related discontinuations, and no clinically meaningful changes in laboratory values, ECGs, or vital signs. Compliance with the five-day dosing regimen was high.

 

“These findings provide confirmation of an early clinical trials antiviral effect and support further evaluation of ProLectin-M’s novel galectin-targeting mechanism,” said David Platt, PhD, CEO of Bioxytran. 

 

“The clinical trials results are opening a new horizon for a new generation of safe anti-viral drugs. We believe the consistency of the observed activity supports continued clinical development of this oral therapeutic approach.”