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.
