Dose optimization data expected to support regulatory discussions and future pivotal trial planning
BOSTON, Oct. 29, 2025 — Bioxytran, Inc. (OTCQB: BIXT), a clinical-stage biotechnology company developing carbohydrate-based therapeutics for viral diseases and other significant unmet medical needs, today announced the successful completion of its latest randomized, double-blind, placebo-controlled clinical study evaluating ProLectin-M, the Company's lead investigational antiviral candidate.
The study was designed to further evaluate ProLectin-M's safety, antiviral activity, and optimal dosing regimen as Bioxytran prepares for the next stage of clinical development. Results from the trial are expected to support ongoing regulatory discussions with both the U.S. Food and Drug Administration (FDA) and India's Central Drugs Standard Control Organization (CDSCO) regarding the design of a planned Phase 3 registrational study.
The completed study represents another important milestone in Bioxytran's clinical development program for ProLectin-M.
Earlier randomized clinical studies demonstrated rapid reductions in detectable viral RNA among treated participants with mild-to-moderate COVID-19. The newly completed trial was designed to further evaluate dosing while confirming the safety and antiviral activity observed in previous studies.
Bioxytran expects the data generated from this study to help identify the dosing regimen intended for evaluation in future registrational studies while strengthening the overall clinical evidence supporting ProLectin-M's continued development.
ProLectin-M is an investigational oral therapeutic developed using Bioxytran's proprietary carbohydrate drug design platform.
Unlike antiviral therapies that primarily inhibit viral replication after infection has occurred, ProLectin-M is designed to interfere with galectin-mediated viral attachment and entry into host cells. By targeting host-pathogen interactions rather than viral proteins alone, the Company believes this differentiated mechanism may offer opportunities for broader antiviral applications that warrant continued clinical investigation.
Bioxytran continues to evaluate this galectin-targeted approach across multiple viral diseases as part of its broader glycovirology platform.
The Company intends to use findings from the completed trial to support regulatory planning for its next phase of clinical development.
Dose optimization results are expected to inform discussions with regulatory authorities regarding the design of a planned Phase 3 registrational study. Bioxytran anticipates submitting the study data to both the FDA and CDSCO as part of its ongoing regulatory engagement.
Completion of this study represents another step toward advancing ProLectin-M through the clinical development pathway.
Bioxytran plans to compile the complete clinical findings, including safety and efficacy analyses, for submission to a peer-reviewed scientific journal.
Publication of the study results is expected to contribute to the growing body of research surrounding galectin-targeted antiviral therapies and carbohydrate-based drug development.
"The completion of this randomized clinical study marks another important milestone in the development of ProLectin-M," said David Platt, PhD, Chief Executive Officer of Bioxytran.
"Each successive clinical study expands our understanding of this investigational therapy and helps guide the next stage of development. We believe the data generated through this program continue to support the scientific rationale behind our carbohydrate-based antiviral platform as we work toward future regulatory milestones."
ProLectin-M represents one component of Bioxytran's broader platform strategy focused on carbohydrate-based therapeutics.
The Company's antiviral research combines expertise in:
Through this platform, Bioxytran is investigating novel approaches for addressing viral diseases where current treatment options remain limited while exploring broader applications of galectin-targeted therapeutics across multiple infectious diseases.
Bioxytran, Inc. is a clinical-stage biotechnology company developing investigational carbohydrate-based therapeutics designed to address viral diseases, inflammation, fibrosis, hypoxia, and other serious medical conditions.
The Company's proprietary research platform combines glycovirology, galectin biology, carbohydrate chemistry, and oxygen therapeutic technologies to investigate innovative approaches for treating diseases where conventional therapies remain limited. Its lead investigational programs include ProLectin-M, a galectin antagonist being studied for viral diseases, and BXT-25, an investigational oxygen therapeutic platform designed to improve oxygen delivery during tissue hypoxia.
This news release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding ProLectin-M, planned regulatory submissions, anticipated Phase 3 development, clinical trial outcomes, publication of study results, future regulatory discussions, and the potential applications of Bioxytran's investigational technologies. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks include clinical trial outcomes, regulatory decisions, funding availability, development timelines, commercialization efforts, and other factors described in the Company's filings with the U.S. Securities and Exchange Commission. Bioxytran undertakes no obligation to update forward-looking statements except as required by law.
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Bioxytran, Inc.
Website: www.bioxytraninc.com
Investor Contact:
David Platt, PhD
Chief Executive Officer
Bioxytran, Inc.
617-484-1199
info@bioxytraninc.com
