Bioxytran Announces Positive Dose Optimization Results and Advances Toward Phase 3 Registrational Trial for ProLectin-M

Rhea-AI Summary

Bioxytran (OTCQB: BIXT) reported positive dose optimization for ProLectin-M and outlined plans toward a Phase 3 registrational trial. A 39-participant study identified a 16,800 mg/day regimen achieving 90% viral clearance by Day 5 with a favorable safety profile. The company is in discussions with the FDA and India’s CDSCO and proposes a ~408‑participant randomized, placebo-controlled outpatient Phase 3 trial for standard‑risk patients with mild‑to‑moderate COVID-19 and other viral infections.

Bioxytran also reported in vitro activity versus RSV and H1N1, a University of Georgia collaboration on H5N1 research, and advancement of an IV formulation for Long COVID.

Positive

• 16,800 mg/day dosing achieved 90% viral clearance by Day 5
• Company entering regulatory talks with FDA and CDSCO
• Planned 408‑participant randomized, placebo‑controlled Phase 3 registrational trial
• In vitro antiviral activity shown against RSV and H1N1
• Research collaboration with University of Georgia on H5N1

Negative

• Dose optimization based on a 39‑participant study (limited sample size)
• No completed Phase 3 or regulatory approval yet

Company Initiates Regulatory Discussions with CDSCO; Plans 408-Patient Pivotal Study Targeting Standard-Risk Several Viral Infected Outpatients

BOSTON, March 04, 2026 (GLOBE NEWSWIRE) -- Bioxytran, Inc. (OTCQB: BIXT) today announced positive dose optimization results for its lead antiviral candidate, ProLectin-M, and provided an update on the Company’s planned Phase 3 registrational trial. The data, released March 2, 2026, were designed to establish the optimal dosing strategy and support advancement into a pivotal study intended to enable full regulatory approval.

Phase 3 Registrational Trial Overview

Bioxytran has entered regulatory discussions with the U.S. Food and Drug Administration (FDA) and India’s Central Drugs Standard Control Organization (India regulator) to finalize the design of a Phase 3 registrational trial.

Planned key elements include:

• Study Size: Approximately 408 participants
• Design: Randomized, placebo-controlled, outpatient study
• Primary Endpoint: Statistically significant viral clearance or clinical improvement by Day 5 compared to placebo
• Target Population: Standard-risk patients with mild-to-moderate COVID-19 and other viral infections from Influenza, RSV and other viruses

The Company intends for the Phase 3 trial to serve as the final clinical step toward potential regulatory approval.

Dose Optimization Confirms 16,800 mg/day as Target Regimen

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. 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.

Differentiated Mechanism: Galectin Antagonism

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 observed with certain antiviral classes
• Minimal drug-to-drug interaction concerns to date
• Broad applicability across viral variants due to targeting conserved structural elements involved in viral attachment

Expanding the Platform Beyond COVID-19

Bioxytran is also evaluating the broader antiviral potential of its galectin antagonist platform.

On February 23, 2026, the Company initiated a research collaboration with the University of Georgia to evaluate its compound (PHM23) against H5N1 avian influenza strains as part of a federally supported initiative aimed at mitigating poultry losses.

In addition, in vitro studies have demonstrated viral load reduction against RSV and H1N1 influenza strains. The Company is also advancing ProLectin-I, an intravenous formulation, for investigation in Long COVID.

Corporate Outlook

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. The Company will provide additional updates as regulatory discussions progress and timelines are finalized.

About Bioxytran, Inc.

Bioxytran, Inc. is a clinical-stage biotechnology company developing galectin antagonist therapies for viral diseases and other indications. The Company’s lead product candidate, ProLectin-M, is designed to block viral entry into cells through galectin modulation.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the planned Phase 3 registrational trial, regulatory discussions with the FDA and CDSCO, anticipated trial design, patient enrollment targets, expected endpoints, potential regulatory approval, expansion into additional viral indications, and the therapeutic potential of ProLectin-M and ProLectin-I. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those described. Risks and uncertainties include, among others, the outcome of regulatory discussions, the ability to initiate and complete clinical trial results, regulatory approval processes, market conditions, and other factors described in the Company’s filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to update forward-looking statements except as required by law.

For more information, please visit:
www.bioxytraninc.com
Investor Contact:
David Platt, PhD
CEO, Bioxytran, Inc.
617-484-1199
David.Platt@bioxytraninc.com
SOURCE: BioXyTran, Inc.

FAQ

What did Bioxytran (BIXT) report on March 2, 2026 about ProLectin-M dosing?

The company reported a 16,800 mg/day target regimen that achieved 90% viral clearance by Day 5. According to the company, this result came from a 39‑participant dose optimization study showing favorable tolerability and antiviral activity.

What Phase 3 trial is Bioxytran (BIXT) planning for ProLectin-M and who will it enroll?

Bioxytran plans an outpatient, randomized, placebo‑controlled Phase 3 of about 408 participants. According to the company, the trial targets standard‑risk patients with mild‑to‑moderate COVID‑19 and other viral infections including influenza and RSV.

Has Bioxytran (BIXT) engaged regulators for the Phase 3 ProLectin-M study?

Yes. Bioxytran is in regulatory discussions with the FDA and India’s CDSCO to finalize Phase 3 design and endpoints. According to the company, these talks aim to align trial elements toward potential registrational submission.

Does ProLectin-M show activity beyond COVID-19 according to Bioxytran (BIXT)?

Bioxytran reports in vitro viral load reduction against RSV and H1N1, and a research collaboration on H5N1. According to the company, these findings support broader antiviral potential for its galectin antagonist platform.

What mechanism does ProLectin-M use and how does Bioxytran (BIXT) position it versus other antivirals?

ProLectin‑M is a galectin antagonist designed to block viral entry into cells, not replication. According to the company, this entry‑blocking approach may reduce drug interactions and target conserved attachment elements across variants.

What are the near‑term regulatory and clinical milestones for Bioxytran (BIXT)?

Near term, Bioxytran aims to finalize Phase 3 design with regulators and initiate the ~408‑participant pivotal trial. According to the company, additional updates will follow as regulatory discussions conclude and timelines are set.