Star Metro - BioNxt Delivers Positive Results in Patented Cladribine Sublingual Thin-Film Program and Completes Successful Formulation

The cladribine API was used by BioNxt's European drug development partner, Gen-Plus GmbH & Co. KG, based in Munich, Germany, to develop and produce prototype oral dissolvable films (ODFs). These initial formulations demonstrated promising characteristics in terms of drug loading, film uniformity, and disintegration time, confirming the suitability of cladribine for thin-film drug delivery.

This formulation milestone strengthens the foundation for clinical batch manufacturing and further optimization, which are ongoing as part of BioNxt's strategy to initiate a human bioequivalence study in the second half of 2025.

Strategic Milestone in BioNxt's Cladribine Development Path

BNT23001 is designed to offer a patient-centric alternative to conventional oral cladribine tablets, such as Mavenclad®, by delivering the drug through a rapidly dissolving sublingual film. This approach aims to improve treatment adherence, particularly for MS patients who experience dysphagia, a common symptom that affects the ability to swallow.

BioNxt's proprietary thin-film platform enables precise and rapid drug absorption via the oral mucosa, offering potential advantages in bioavailability, convenience, and patient experience over traditional oral or injectable formats.

In parallel with formulation progress, BioNxt continues to advance its intellectual property strategy. The company believes that continued validation of the product and further experimental data will support additional IP filings, with patent protection representing a key upcoming milestone for BNT23001. BioNxt has already initiated patent nationalization processes in Europe, the United States, and Canada.

"The successful formulation of the first cladribine-containing thin-film prototype marks a major step forward in the clinical development of BNT23001," said Hugh Rogers, CEO of BioNxt Solutions. "It also underscores the strength of our drug delivery platform as we move toward human trials and eventual commercial readiness."

BioNxt expects to continue formulation optimization and begin in vitro performance testing, with preclinical evaluation to follow as the Company advances toward regulatory readiness and potential out-licensing opportunities.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.

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: [email protected]
Phone: +1 778.598.2698

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 statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.

Mavenclad® is a registered trademark of Merck KGaA, Darmstadt, Germany. It is not affiliated with or endorsed by BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

F.Davis--SMC