Bioxytran Reports Positive Dose Optimization Results, Advances ProLectin-M Toward Phase 3 Trial

(RTTNews) - 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, establish the optimal dosing strategy and support advancement into a pivotal study intended to enable full regulatory approval.

The company has entered regulatory discussions with the U.S. Food and Drug Administration (FDA) and India's Central Drugs Standard Control Organization to finalize the design of the Phase 3 trial. The study is expected to enroll approximately 408 participants in a randomized, placebo-controlled outpatient setting. 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 as well as other viral infections, including influenza and RSV.

Dose optimization confirmed that a 16,800 mg/day regimen achieved 90% viral clearance by Day 5 while maintaining a favorable safety profile. Earlier stages had evaluated lower doses, but the March 2 data identified 16,800 mg/day as the optimal balance between antiviral activity and tolerability, providing clarity as the company advances into Phase 3 planning.

ProLectin-M employs a differentiated mechanism of action through galectin antagonism, designed to block viral entry into host cells. This approach contrasts with replication inhibitors such as Pfizer's Paxlovid, which act after infection has occurred. Bioxytran believes its entry-blocking strategy may offer a potential first-line treatment option, reduce rebound risks, minimize drug-to-drug interactions, and maintain broad applicability across viral variants.

Beyond COVID-19, Bioxytran is expanding its galectin antagonist platform. On February 23, 2026, the company initiated a collaboration with the University of Georgia to evaluate compound PHM23 against H5N1 avian influenza strains, part of a federally supported initiative to mitigate poultry losses. In vitro studies have also demonstrated viral load reduction against RSV and H1N1 influenza, while an intravenous formulation, ProLectin-I, is being advanced for investigation in Long COVID.

With dose optimization complete and regulatory engagement underway, Bioxytran believes it has established the scientific and clinical foundation necessary to proceed into a pivotal Phase 3 registrational trial.

Bioxytran, trading on the OTC Markets, closed at $0.0428 on March 4, 2026. The stock rose by $0.0026, marking a 6.47% gain at the close of trading at 4:00 PM EST.

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