Lead investigational antiviral candidate continues clinical development under an active FDA Investigational New Drug application
BOSTON, Aug. 7, 2025 — Bioxytran, Inc. (OTCQB: BIXT), a clinical-stage biotechnology company developing investigational carbohydrate-based therapeutics for viral diseases and other significant unmet medical needs, today announced the completion of dosing in its dose optimization clinical study evaluating ProLectin-M, the Company's lead investigational oral antiviral candidate.
The completion of dosing represents an important milestone in Bioxytran's ongoing clinical development program. The study was designed to evaluate dosing of ProLectin-M and provide additional clinical data to help guide the Company's development strategy and future regulatory discussions.
ProLectin-M is currently being developed under an active Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
ProLectin-M is an investigational oral therapeutic based on Bioxytran's proprietary linear complex carbohydrate chemistry.
The candidate is being developed within Bioxytran's glycovirology platform, which investigates the role of carbohydrate-protein interactions in viral attachment and infection.
Preclinical research has investigated ProLectin-M's interaction with galectin-related structures involved in viral attachment. The Company's research has evaluated its potential activity against respiratory viruses including SARS-CoV-2, influenza, and respiratory syncytial virus (RSV).
Bioxytran is also continuing research into the potential application of its galectin-targeted approach across additional viral diseases.
The dose optimization study follows earlier randomized, double-blind, placebo-controlled clinical research evaluating ProLectin-M in participants with mild-to-moderate COVID-19.
According to data previously reported by the Company, earlier clinical studies observed rapid reductions in detectable viral RNA among treated participants. Previous company-reported results included an 88% negative PCR response by Day 3 and a 100% negative PCR response by Day 7 in the study population.
These findings are part of the clinical evidence being evaluated as Bioxytran continues development of ProLectin-M. The dose optimization study was undertaken to provide additional information regarding dosing, safety, and antiviral activity.
As with all investigational therapies, additional clinical research is required to establish the safety and efficacy of ProLectin-M and to determine its potential role in the treatment of viral infections.
Dose optimization is an important component of clinical drug development because establishing an appropriate dose requires balancing pharmacologic activity, tolerability, and other safety considerations.
Data generated through the completed study are expected to contribute to Bioxytran's ongoing development and regulatory planning for ProLectin-M.
The Company intends to use the clinical data in its continued engagement with regulatory authorities as it evaluates the next stages of development.
Many conventional antiviral therapies target viral enzymes or other components involved in replication after infection has been established.
Bioxytran's approach is based on investigating viral entry and host-pathogen interactions.
ProLectin-M is designed to interact with galectin-mediated pathways associated with viral attachment. This approach forms part of Bioxytran's broader research into whether carbohydrate-based therapeutics can interfere with early stages of viral infection.
The scientific rationale behind this strategy is being investigated through laboratory studies and clinical development programs.
Bioxytran's glycovirology platform is not limited to a single viral target.
Research involving ProLectin-M and related carbohydrate-based approaches has included respiratory viruses such as:
The Company is also investigating whether galectin-targeted carbohydrate chemistry may have applications against additional viral pathogens.
This platform approach allows Bioxytran to explore whether a common biological mechanism involved in viral attachment can provide opportunities across multiple infectious diseases.
The development of ProLectin-M reflects Bioxytran's broader focus on carbohydrate drug design.
Carbohydrates participate in numerous biological interactions, including cell recognition, adhesion, immune signaling, and host-pathogen interactions. Bioxytran's research applies carbohydrate chemistry to the development of investigational therapeutics designed to interact with disease-related biological pathways.
The Company's glycovirology research combines carbohydrate chemistry with galectin biology to investigate new approaches to antiviral drug development.
With dosing completed in the dose optimization study, Bioxytran will continue analyzing the resulting clinical data and assessing their implications for the next stage of ProLectin-M development.
The Company expects the study findings to contribute to its ongoing regulatory strategy and future clinical planning.
Additional clinical development will be required before ProLectin-M can be considered for regulatory approval or routine clinical use.
Bioxytran, Inc. is a clinical-stage biotechnology company developing investigational carbohydrate-based therapeutics designed to address significant unmet medical needs.
The Company's research platform combines glycovirology, carbohydrate drug design, galectin biology, and oxygen therapeutics to investigate novel approaches to viral diseases, hypoxia, inflammation, fibrosis, and tissue injury.
Bioxytran's lead investigational antiviral candidate, ProLectin-M, is an orally administered galectin antagonist being studied for viral diseases. The Company is also advancing research into oxygen therapeutic technologies for conditions associated with tissue hypoxia.
This news release contains forward-looking statements within the meaning of applicable securities laws, including statements concerning the development of ProLectin-M, analysis of clinical data, regulatory discussions, future clinical studies, potential indications, and the potential therapeutic applications of Bioxytran's investigational technologies. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied.
Factors that may affect future results include clinical trial outcomes, regulatory decisions, funding availability, development timelines, manufacturing considerations, strategic partnerships, and other risks described in Bioxytran's filings with the U.S. Securities and Exchange Commission. Bioxytran undertakes no obligation to update forward-looking statements except as required by applicable law.
Bioxytran, Inc.
Website: www.bioxytraninc.com
Investor Contact:
David Platt, PhD
Chief Executive Officer
Bioxytran, Inc.
