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BioNxt Solutions Advances Towards Human Trials for BNT23001

BioNxt Solutions Inc. (CSE:BNXT) has entered a crucial stage in the development of its lead product, BNT23001, a next-generation formulation aimed at treating multiple sclerosis (MS). The company has announced the commencement of a 15-day dosing optimization study, a pivotal step before starting human bioequivalence testing, expected to kick off in early 2026.

Following a series of successful small-animal trials that confirmed bioequivalence, BioNxt is now proceeding with the final preparations for its sublingual Cladribine formulation. This latest study involves a large-mass animal trial, which aims to refine dosage accuracy and enhance the efficacy of the formulation prior to human trials.

"Our previous studies have established bioequivalence in smaller animals. Now, we will explore the formulation's effects in larger subjects, which will guide our understanding of how to optimize dosing for human patients," remarked Hugh Rogers, CEO of BioNxt Solutions. He detailed how insights from this research are critical, as they will inform the design of the future human bioequivalence trial, enhancing precision in drug administration.

The upcoming crossover study is slated to launch within two weeks, running for approximately three weeks, with results anticipated in December. This is a critical moment for BioNxt as they strive to create a more effective delivery method for MS treatments.

Transformative Approach to MS Treatment

BNT23001 is designed as an orally dissolvable thin-film formulation of Cladribine, a well-established immunomodulatory agent used in MS therapies. This formulation aims to improve patient experience by promoting faster absorption and enhancing bioavailability while accommodating those who struggle with traditional tablets.

Preclinical evaluations have indicated promising absorption rates, comparable efficacy to standard oral treatments, and no observed toxicity. These findings strengthen the case for BNT23001 as a more patient-friendly option for managing MS, offering hope for those requiring alternative methods of administration.

Expansion of Patent Protection

Recognizing the importance of intellectual property, BioNxt Solutions is advancing its patent strategy to secure protections across vital markets. Countries such as Canada, Australia, the European Union, Eurasia, New Zealand, and Japan are on the list for patent applications, alongside a priority filing in the United States.

Notably, both the European and Eurasian Patent Offices have issued encouraging communications, indicating the acceptance of the company's claims regarding novelty, inventive step, and industrial applicability. This solidifies BioNxt’s position as it transitions towards human trials.

Future Outlook for 2026

The comparative bioequivalence study will directly assess how BioNxt's sublingual formulation stacks up against the existing tablet version of Cladribine. The objective is to verify that this innovative approach can provide a quicker and more patient-centric method for MS treatments.

With ongoing dosing optimizations and an expanding patent portfolio, BioNxt Solutions is on the brink of a transformative phase. The successful rollout of BNT23001 has the potential to redefine not only how MS medications are administered but also how patients experience their treatment journey.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is at the forefront of bioscience innovation, working on advanced drug delivery systems, diagnostic tools, and active pharmaceutical ingredients. With a focus on patient-centric solutions, their research spans across North America and Europe, aimed at enhancing healthcare outcomes for patients worldwide. The company is publicly traded on the Canadian Securities Exchange under the ticker BNXT, as well as on OTC Markets (BNXTF) and in Germany (WKN A3D1K3).

To explore more about BioNxt and its developments, visit www.bionxt.com.