Bioxytran has announced encouraging results from a randomized, double‑blind, placebo‑controlled phase 1b/2a study of its oral antiviral ProLectin‑M in patients hospitalised with mild to moderate COVID‑19.
The company said the highest evaluated dose of 16,800 mg/day led to significantly earlier viral clearance and faster clinical improvement by day 5 compared with placebo, with 90% of patients clearing the virus versus 20% in the placebo arm.
By day 7, viral clearance was seen across all study groups, which the company noted is consistent with the expected natural course of infection. No serious adverse events were reported and no patients discontinued treatment because of side effects, supporting what Bioxytran described as a favourable safety and tolerability profile.
Dr Leslie Ajayi, Bioxytran’s Chief Medical Officer, said: “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.”
Dr Ajayi added: “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.”
David Platt, CEO of Bioxytran, said: “These findings provide confirmation of an early clinical trials antiviral effect and support further evaluation of ProLectin-M’s novel galectin-targeting mechanism.” Platt added: “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.”
The study enrolled 39 participants in India with RT‑PCR‑confirmed SARS‑CoV‑2 infection and mild to moderate disease. Patients were randomised to receive one of three dose levels of ProLectin‑M plus standard of care or placebo plus standard of care over five days.
