Bioxytran Announces Positive Phase 2 Trial Results were Featured in “Vaccines” a Peer-Reviewed Journal

Rhea-AI Summary

Bioxytran, Inc. (BIXT) announced promising results from a Phase 2 clinical trial for its Galectin antagonist, demonstrating a 100% viral load elimination in 34 patients with mild-to-moderate COVID-19 by day 7, compared to just 6% in the placebo group (p=.001). Most symptoms resolved within the same period. The trial showed an 82% responder rate by day 3 (p=.001) with no serious adverse events. These results support further studies, possibly a Phase 3 trial, highlighting the drug's potential in both treatment and prophylaxis against viral infections. Bioxytran aims to explore applications beyond COVID-19, tapping into Glycovirology.

Positive

• 100% elimination of viral load in treated patients by day 7 vs 6% in placebo (p=.001).
• 82% responder rate by day 3 (p=.001) with no serious adverse events.
• Successful trial supports next steps towards Phase 3 study.

Negative

• None.

Complete elimination of viral load in 100% of patients at day 7 vs 6% in placebo (p=.001)
Complete elimination of most symptoms by day 7
Galectin antagonist acts as an entry inhibitor for use in treatment of COVID-19

BOSTON, MASSACHUSETTS, March 29, 2023 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that the journal “Vaccines” released a peer-reviewed article, “An Oral Galectin Inhibitor in COVID-19 – A Phase 2 Randomized Controlled Trial”, which contains top-line safety and efficacy results of the Company’s randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19. During the 7 days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered. The endpoint was a statistically significant reduction in viral load measured by the number of patients reaching a below threshold PCR value (Ct value ≥ 29) by day 7. Additionally, most of the symptoms completely disappeared in the group receiving the drug whereas the placebo group had 41.18% of patients that continued to experience chills, 29.41% that had a feverish sensation, and 35.29% that had a cough on day 7. The trial met its endpoint with a 100% response rate by day 7 versus 6% in placebo, which was statistically significant (p-value =.001).

Our analysis also revealed an 82% responders rate by day 3, which was statistically significant (p-value = .001). There were no drug-related serious adverse events (SAE’s) in the patient population or viral rebounds by day 14. The positive data from this clinical trial provided the rationale of dosing and protocol design for study in an upcoming phase 2/3 registrational trial.

The full text of the journal article is located at the following link.
https://www.mdpi.com/2076-393X/11/4/731

“After considering all the clinical data and tests it is clear that ProLectin-M could play a major role in treating future pandemics. The drug dramatically reduced the viral load which in turn shuts down the transmission of the virus. Recent analysis reveals that reducing the number of days of infectivity can have a dramatic impact on the number of overall infections, hospitalizations, and economic burden” said Dr. Alben Sigamani, a member of Bioxytran’s Medical Advisory Board. Dr. Sigamani continued by stating “The key to stopping this cycle of immune evasion is to quickly treat the infected and provide prophylaxis to those exposed. The trial results demonstrate we may be able to do both. This is why we are looking forward to starting our dosage optimization study which will inform our Phase 3 study and future trial designs.”

“Existing therapies target viral replication which battles on the inside of the cell interfering with replication, our Galectin Antagonist helps keep the fight outside the cell interfering with cellular entry. This novel Mechanism of Action in battling viruses may require little assistance from the immune system, which typically requires a lead time to mount a response. With the creation of this molecule, we contribute to the science of Glycovirology, which is the study of carbohydrates and viruses.”

“This is truly a groundbreaking study that demonstrates the proof of concept of a carbohydrate molecule capable to influence and block infection by a virus.” said Dr. Hana Chen-Walden, Medical Director of Bioxytran. “In the past, before the COVID-19 epidemic, vaccines were used to stop the viral spread and thus eradicate the disease. This ideal was not supported by the new COVID19 vaccines, in face of the continuation of the spread of the virus with the appearance of new mutant virus variants which were not controlled by the vaccine. It became evident that other tools will have to be used against the spread of disease contributing to its prophylaxis”.

“We intend to explore not only COVID-19, but also other viruses and indications. The underlying concept of Glycovirology, is that viral and human membranes are glycosylated. The Galectin Fold or the protein receptors called Lectins which recognize only carbohydrates chemical structures are unique to each virus. Our challenge will be to identify the unique galectins structure on each virus and then the specific complex carbohydrate chemical structures that will bind to the galectin fold to achieve complete binding and inhibition of viral entry. Recent journal articles have demonstrated the utility of using high power resolution of NMR mathematical calculations as drug design tool to quickly assess the binding affinity theoretically. It is for these reasons we believe we have a vast and major novel platform technology that could effectively treat other serious viral diseases.”

About Bioxytran, Inc.

Bioxytran, Inc. is a clinical stage biotechnology company developing novel therapies targeting the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. The leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. Bioxytran’s other development programs are for pulmonary fibrosis and stroke treatment. More information can be found at 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, 2021 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 were the results of Bioxytran's Phase 2 trial for COVID-19?

Bioxytran's Phase 2 trial showed a 100% elimination of viral load in patients treated with their Galectin antagonist by day 7, compared to 6% in the placebo group, with an 82% responder rate by day 3.

What is the significance of the Phase 2 trial results for BIXT?

The trial results provide a strong rationale for advancing to a Phase 3 study, indicating the potential effectiveness of the Galectin antagonist in treating COVID-19 and possibly other viral infections.

When will the next trial phase for Bioxytran start?

Bioxytran intends to start dosage optimization studies that will inform their Phase 3 study and future trial designs.

What mechanism does Bioxytran's Galectin antagonist use to combat COVID-19?

The Galectin antagonist acts as an entry inhibitor, helping to prevent the virus from entering cells, thus reducing viral replication and the impact of the infection.

How does Bioxytran plan to extend its research beyond COVID-19?

Bioxytran plans to explore applications of their Galectin antagonist for other viral diseases, leveraging the principles of Glycovirology.