Bioxytran, Inc. (BIXT) announced positive dose optimization results for its lead antiviral candidate, ProLectin-M, and provided an update on its planned Phase 3 registrational trial. The data released on March 2, 2026, were designed to establish the optimal dosing strategy and support advancement into a pivotal study intended to enable full regulatory approval.
ProLectin-M utilizes a novel galectin-blocking mechanism designed to interfere with viral entry into host cells. This approach differs from replication inhibitors such as Paxlovid, developed by Pfizer, which target viral proteases after infection has occurred.
Bioxytran believes its entry-blocking strategy may offer a potential first-line treatment option for standard-risk patients, reduced risk of rebound phenomena, minimal drug-to-drug interaction concerns, and broad applicability across viral variants.
The recently completed 39-participant study confirmed that a 16,800 mg/day dosing regimen achieved 90% viral clearance by Day 5 while maintaining a favorable safety profile.
Earlier development stages evaluated lower dose levels, but March 2 data identified 16,800 mg/day as the optimal balance between antiviral activity and tolerability.Bioxytran has entered regulatory discussions with the U.S. FDA and India's Central Drugs Standard Control Organization (CDSCO) to finalize the design of a Phase 3 registrational trial.
Planned key elements include approximately 408 participants, in a randomized, placebo-controlled, outpatient study. The primary endpoint will measure statistically significant viral clearance or clinical improvement by Day 5 compared to placebo, targeting standard-risk patients with mild-to-moderate COVID-19 and other viral infections such as influenza and RSV.
The company intends for the Phase 3 trial to serve as the final clinical step toward potential regulatory approval. Bioxytran is also evaluating the broader antiviral potential of its galectin antagonist platform beyond COVID-19.
BIXT has traded between $0.03 and $0.2 over the past year. The stock closed Wednesday's trading at $0.04, up 6.47%.
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