Bioxytran Completes Randomized Clinical Trial For its Broad-Spectrum Antiviral Drug

Rhea-AI Summary

Bioxytran (OTCQB: BIXT) announced on October 29, 2025 the completion of a randomized, double-blind, placebo-controlled dose-optimization trial for its oral broad-spectrum antiviral candidate ProLectin-M. The company says prior Phase 2 results showed treated participants reached undetectable PCR viral levels in less than one week. Data from the new trial will be used to inform a phase 3 trial design for CDSCO and will be submitted to the FDA at the agency's request. Bioxytran expects to compile detailed safety and efficacy endpoints for peer-reviewed publication and plans to submit full results in the coming weeks.

Positive

• Completed randomized double-blind, placebo-controlled trial on Oct 29, 2025
• Prior Phase 2: undetectable PCR in treated participants in <1 week
• Planned regulatory submissions to CDSCO and FDA
• Company expects peer-reviewed publication of full trial data in coming weeks

Negative

• Full efficacy and safety data not yet released or peer-reviewed
• No phase 3 approval or authorization yet; next steps depend on regulatory review
• Press release gives no quantitative safety endpoints or participant counts

News Market Reaction

+9.27%

1 alert

+9.27% News Effect

On the day this news was published, BIXT gained 9.27%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

• Data from the dose optimization trial expected soon
• ProLectin-M is positioned as the first oral antiviral sugar chemistry drug

BOSTON, MASSACHUSETTS, Oct. 29, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company pioneering innovative therapies for viral diseases, is pleased to announce the successful completion of its second randomized double-blind, placebo-controlled clinical trial for its leading broad-spectrum antiviral drug candidate, ProLectin-M. Data from the trial is expected to inform both the CDSCO for a phase 3 trial design and will also be submitted to the FDA pursuant to their request.

This second randomized controlled trial was designed to confirm the groundbreaking results from the Company's earlier Phase 2 study, which demonstrated that ProLectin-M achieved undetectable levels of Polymerase Chain Reaction (PCR) and infection in less than one week in treated participants. The successful execution of this third independent trial significantly strengthens the robust evidence for ProLectin-M's potential as a rapid-acting oral therapeutic for a wide range of viral infections.

The comprehensive data from this third clinical trial, including detailed safety and efficacy endpoints, is expected to be compiled for publication in a peer-reviewed medical journal. The company anticipates that the full results will be submitted for publication in the coming weeks.

"The successful completion of our third trial is a significant achievement for Bioxytran and represents a potential paradigm shift in antiviral therapy," said Dr. David Platt, CEO of Bioxytran. "To have consistently targeted undetectable viral presence by Polymerase Chain Reaction (PCR) in such a short timeframe across multiple trials is a remarkable achievement. As the first oral antiviral based on the power of sugar chemistry, ProLectin-M is on track to deliver a therapeutic that could fundamentally change how the world manages viral outbreaks."

About Bioxytran, Inc.

Bioxytran, Inc. is at the forefront of developing linear complex carbohydrate-based therapeutics to address critical unmet medical needs in its antiviral platform technology.

For more information, visit www.bioxytraninc.com

Investor Relations
Michael Sheikh
509-991-0245
mike.sheikh@bioxytraninc.com

Forward-Looking Statements

This press release includes forward-looking statements as defined under federal law, including those related to the performance of technology described in this press release. These forward-looking statements are generally identified by the words “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements contain these identifying words. Such statements are subject to significant risks, assumptions and uncertainties. Known material factors that could cause Bioxytran’s actual results to differ materially from the results contemplated by such forward-looking statements are described in the forward-looking statements and risk factors in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and those risk factors set forth from time-to-time in other filings with the Securities and Exchange Commission. Bioxytran undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events, or otherwise, except to the extent required under federal securities laws.

FAQ

What did Bioxytran (BIXT) announce on October 29, 2025 about ProLectin-M?

Bioxytran announced completion of a randomized, double-blind, placebo-controlled dose-optimization trial for ProLectin-M and said trial data will be submitted to regulators.

Did ProLectin-M reach undetectable viral levels in trials and how quickly?

The company reports prior Phase 2 results where treated participants reached undetectable PCR viral levels in less than one week.

Will Bioxytran (BIXT) submit ProLectin-M data to regulators and which ones?

Yes; the company said it will inform a phase 3 design for CDSCO and will submit data to the FDA at the agency's request.

When will full ProLectin-M trial results be published for investors?

Bioxytran expects to compile detailed safety and efficacy endpoints and submit full results for peer-reviewed publication in the coming weeks.

Does the October 29, 2025 announcement mean ProLectin-M is approved for use?

No; the announcement describes trial completion and planned regulatory submissions but does not indicate any regulatory approval or authorization.