Bioxytran Reports Positive Phase 2 Results Demonstrating Rapid Viral Clearance with ProLectin-MBioxytran
MWN-AI** Summary
Bioxytran, Inc. (OTCQB: BIXT) has announced promising results from its Phase 2 clinical trial of ProLectin-M, a novel antiviral therapeutic for treating acute viral infections. Conducted as a randomized, double-blind, placebo-controlled dose-optimization trial, the study involved 38 subjects who were randomized to receive varying doses of ProLectin-M or a placebo over a seven-day period. Notably, the trial showed complete elimination of viral load in 100% of patients treated with ProLectin-M by Day 7, a result statistically significant compared to the placebo group (p=.001).
The trial further reaffirms findings from an earlier Phase 2 study that indicated significant reductions in viral load by Day 7, with early clearance observable as soon as Day 3, and no viral rebounds noted during a subsequent 14-day observation period. The design of the trial reflects real-world applications for managing acute viral diseases, focusing on statistically meaningful reductions in viral load.
Key results highlighted that one participant achieved non-detection of viral shedding by Day 3, while a total of 16 were clear by Day 5, and complete clearance was confirmed in all treated subjects by Day 7. Dr. Leslie Ajayi, Chief Medical Officer at Bioxytran, emphasized the rapid viral clearance and its implications for future treatments.
ProLectin-M’s unique mechanism disrupts viral entry at the cell surface rather than targeting viral replication, presenting a potentially transformative approach in antiviral therapy. With these positive results, Bioxytran plans to initiate regulatory discussions to further its late-stage development and explore additional viral indications for ProLectin-M, underscoring its commitment to tackling significant unmet medical needs in virology. For more information, visit www.bioxytraninc.com.
MWN-AI** Analysis
Bioxytran, Inc. (OTCQB: BIXT) has announced promising Phase 2 clinical trial results for its antiviral treatment, ProLectin-M, significantly impacting its market position and attractiveness for investors. The trial reported 100% viral clearance in treated subjects by Day 7, demonstrating rapid efficacy, and statistically significant results (p=0.001) compared to the placebo group.
These results indicate a successful dose-optimization strategy, confirming the treatment's potential as a broad-spectrum antiviral agent. The lack of viral rebound during a 14-day post-treatment observation suggests sustained efficacy, further enhancing investor confidence. As the company prepares for regulatory discussions aimed at late-stage clinical development and broader viral indications, the unique mechanism of action for ProLectin-M—targeting viral entry rather than replication—positions Bioxytran favorably in the antiviral market.
Investors should closely monitor Bioxytran's strategic steps following this success. The company's ongoing commitment to advancing its research and development pipeline could result in additional catalysts that boost its stock value. However, it’s essential to consider the inherent risks outlined in Bioxytran's SEC filings, as the biotechnology industry can be volatile and subject to regulatory hurdles.
In summary, Bioxytran presents a compelling investment opportunity given its recent clinical success and commitment to innovation in virology. Investors are advised to assess market conditions, the company's operational execution, and regulatory pathways moving forward. This positioning could yield significant returns, especially as the demand for effective antiviral therapies continues to grow amidst ongoing global health challenges.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
BOSTON, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Bioxytran, Inc. (OTCQB: BIXT) today announced positive clinical results from its recently completed Phase 2 randomized, double-blind, placebo-controlled, dose-optimization trial evaluating ProLectin-M in subjects with laboratory-confirmed acute viral infection. The Bioxyytran Trial reports complete elimination of viral load in 100% of patients at day 7 versus placebo (p=.001).
The completed Phase 2 clinical study was a randomized, double-blind, placebo-controlled, dose-optimization trial evaluating orally administered ProLectin-M in subjects with acute viral infection. The study enrolled 38 subjects, all of whom completed the study. Subjects were randomized to receive one of three ProLectin-M dose levels or a matching placebo, administered over a seven-day treatment period.
Viral shedding was assessed using RT-PCR analysis of nasopharyngeal swabs collected at predefined timepoints, with viral clearance defined as non-detection of viral RNA below established PCR thresholds.
The study design, endpoints, and duration confirmed Bioxytran’s earlier randomized, placebo-controlled Phase 2 trial, which demonstrated statistically significant reductions in viral load by Day 7, early clearance as soon as Day 3, and no observed viral rebounds during a 14-day post-treatment observation period. The current trial further refined dose selection of four tablets per day and evaluated the reproducibility of rapid viral clearance using the same core virologic assessment methodology.
Topline Viral Clearance Results
Following database lock and unblinding, treatment-wise analyses demonstrated the following outcomes:
- Complete elimination of viral load in 100% of treated subjects by Day 7, compared to the placebo group (p = .001)
- No viral rebounds observed in the treated population during the 14-day post-treatment observation period
These results indicate rapid and sustained viral clearance in subjects treated with ProLectin-M.
Viral Clearance Timing (All Subjects)
Across the full study population:
- Day 3: 1 of 38 subjects demonstrated non-detection of viral shedding
- Day 5: 16 of 38 subjects demonstrated non-detection of viral shedding
- Day 7: 38 of 38 subjects demonstrated non-detection of viral shedding
The study was designed to evaluate viral clearance kinetics and inform dose selection for future late-stage clinical development.
“The study design of seven days reflects real-world applications for treating acute viral diseases, with the objective of demonstrating a statistically meaningful reduction in viral load by Day 7,” said Dr. Leslie Ajayi, Chief Medical Officer of Bioxytran. “The results demonstrate that viral clearance occurred more rapidly than anticipated, with a significant proportion of treated subjects achieving viral non-detection by Day 3 and complete clearance by Day 7.”
“What continues to distinguish ProLectin-M as a broad-range antiviral drug is its novel mechanism of action,” Dr. Platt continued. “Rather than targeting viral replication inside the cell, our galectin antagonist is designed to interfere with viral entry at the cell surface. This extracellular approach may reduce reliance on immune activation and represents a fundamentally different strategy in antiviral therapy. We believe these results further support the potential of carbohydrate-based therapeutics and the emerging field of Glycovirology.”
Next Steps
Based on these results, Bioxytran plans to advance regulatory discussions to support late-stage clinical development and evaluate ProLectin-M across additional viral indications consistent with its broad-spectrum antiviral profile.
About Bioxytran, Inc.
Bioxytran, Inc. is a clinical-stage biotechnology company developing novel carbohydrate-based therapeutics targeting significant unmet medical needs in virology and other disease areas. The Company’s lead program, ProLectin-M, is being developed as a potential broad-spectrum antiviral therapeutic.
For more information, please visit www.bioxytraninc.com.
Investor & Media Contact:
Bryan Feinberg / AmplifiX
Zephyr@amplifiX.net
Company Contact:
david.platt@bioxytraninc.com
(617) 510-2539
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable federal securities laws, including statements regarding the performance of the technology described herein, the interpretation of clinical trial results, regulatory plans, and future development activities. Forward-looking statements are generally identified by words such as “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and similar expressions, although not all forward-looking statements include these terms. Such statements are subject to significant risks, uncertainties, and assumptions that could cause actual results to differ materially from those expressed or implied. These risks are described in Bioxytran’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and other filings made from time to time. Bioxytran undertakes no obligation to update or revise any forward-looking statements, except as required under applicable securities laws.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/37657855-933f-4c06-910c-45e4ec67bc02
FAQ**
What are the potential implications of Bioxytran Inc BIXT's recent Phase 2 trial results for the future development of ProLectin-M in treating various viral infections?
How does ProLectin-M’s novel mechanism of action differ from traditional antiviral therapies, and what does this mean for Bioxytran Inc BIXT’s market positioning?
Considering the positive results reported by Bioxytran Inc BIXT, what are the anticipated regulatory challenges the company may face as it moves towards late-stage clinical development?
What plans does Bioxytran Inc BIXT have for expanding the use of ProLectin-M beyond the current indications based on the trial outcomes, and how might this impact the company’s growth trajectory?
**MWN-AI FAQ is based on asking OpenAI questions about Bioxytran Inc (OTC: BIXT).
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