New York, USA, October 22nd, 2025, FinanceWire
BioNxt Solutions Inc. (CSE:BNXT) (OTCQB:BNXTF) (FSE:BXT), a bioscience company developing next-generation drug delivery technologies, has launched a 15-day dosing optimization study for its lead product BNT23001, a proprietary sublingual Cladribine formulation for the treatment of multiple sclerosis (MS).
The study marks the final step before human bioequivalence testing, which is set to begin in early 2026.
A Final Step Before Human Testing
Following successful small-animal trials that confirmed bioequivalence, BioNxt is now taking the final preclinical step to prepare its sublingual Cladribine formulation for human testing. The upcoming large-mass animal study is designed to fine-tune dosing precision and optimize the formulation ahead of the company’s comparative human bioequivalence trial planned for early 2026.
“The company has already confirmed dosage bioequivalence in small-mass (<20kgs) animals; however, a large-mass (>40kgs) animal study will provide valuable insight into the appropriate sublingual drug load for humans,” said BioNxt Solutions Inc. (CSE:BNXT) (OTCQB:BNXTF) (FSE: BXT) CEO Hugh Rogers.
“This large-mass animal study is expected to increase the formula precision in our human study and is designed to generate comparative drug absorption results between the Company’s sublingual formulation versus the name brand tablet formulation. Optimization of drug load per dose and potential super bioavailability are key pieces of information that will guide the final clinical planning for our upcoming comparative human bioequivalence study.” he added.
The 15-day crossover study is set to begin within the next two weeks and will run for approximately three weeks. Completion is expected in November, with results due in December.
Transforming How MS Drugs Are Delivered
BNT23001 is an orally dissolvable thin-film formulation of cladribine, an established immunomodulatory compound used to treat multiple sclerosis. Delivered under the tongue, the therapy is designed to offer faster absorption, improved bioavailability, and greater patient comfort, especially for those who have difficulty swallowing tablets or prefer a non-invasive alternative.
Preclinical testing has shown strong absorption rates, bioequivalence to standard oral treatments, and no signs of toxicity, supporting the drug’s potential as a more convenient option for MS patients.
Patent Protection Expanding Worldwide
BioNxt Solutions Inc. (CSE:BNXT) (OTCQB:BNXTF) (FSE: BXT) is also advancing its patent nationalization strategy across key markets, including Canada, Australia, the European Union, Eurasia, New Zealand, and Japan, along with a Track One priority filing in the US.
Both the European Patent Office and the Eurasian Patent Office have issued favorable communications, including intent-to-grant notices. Novelty, inventive step, and industrial applicability have all been accepted, reinforcing the company’s IP position ahead of human trials.
Positioning for 2026 Human Trials
The upcoming human comparative bioequivalence study will directly measure drug absorption between BioNxt’s sublingual formulation and the existing tablet version of Cladribine. The goal: to validate a simpler, faster, and more patient-friendly approach to MS treatment.
With dosing optimization underway and patent protections expanding, BioNxt Solutions Inc. (CSE:BNXT) (OTCQB:BNXTF) (FSE: BXT) is entering a pivotal phase that could redefine how MS medications are delivered and how patients experience them.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects. With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3.
To learn more about BioNxt, please visit www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 604.250.6162
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding “Forward-Looking” Information
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws (collectively, “forward-looking information”). Such information may include, but is not limited to, statements regarding: the anticipated grant, scope, and timing of European, Eurasian, and other international patent rights; the Company’s plans for additional national filings; the development, clinical evaluation, regulatory approval, and commercialization of the Company’s Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, cost, and outcome of preclinical and clinical studies; and the potential application of BioNxt’s sublingual thin-film drug delivery platform across additional therapeutic areas.
Forward-looking information is based on management’s current expectations, assumptions, estimates, and projections as of the date of this press release. Such statements are subject to inherent risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to: outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs of preclinical and clinical studies; scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.
Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions underlying such information are reasonable, there can be no assurance that they will prove to be correct. Except as required under applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.
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Contact
Huge Rogers
investor.relations@bionxt.com
Contact
Huge Rogers
investor.relations@bionxt.com
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