BioNxt Solutions (OTC: BNXTF) has cleared a critical regulatory hurdle in Europe, with the European Patent Office (EPO) formally signaling its intent to grant the company a foundational patent for its sublingual drug delivery platform targeting autoimmune neurodegenerative diseases. The technology underpins BioNxt’s most advanced asset, BNT23001—a rapidly dissolving oral film formulation of Cladribine positioned as a potential game-changer for multiple sclerosis (MS) treatment.
This milestone accelerates BioNxt’s global intellectual property strategy, with parallel patent filings advancing through the Eurasian Patent Organization and key markets including the U.S., Japan, and Australia. The company’s pipeline—which spans MS, myasthenia gravis, and lupus nephritis—could disrupt traditional injection-based therapies by offering patients needle-free alternatives with improved bioavailability.
Strategic Implications
- European patent grant strengthens BioNxt’s negotiating power for regional partnerships
- Sublingual delivery platform creates optionality across multiple autoimmune indications
- Upcoming BNT23001 bioequivalence study could validate faster route to European approval
- Global IP expansion de-risks commercialization pathways in $150B+ autoimmune drug market
05/23/2025 – 03:05 AM
VANCOUVER, BC / ACCESS Newswire / May 23, 2025 / BioNxt Solutions Inc. (CSE:BNXT) has achieved a pivotal regulatory milestone as the European Patent Office moves to grant protection for its proprietary sublingual drug delivery technology. The decision comes at a strategic inflection point for the bioscience firm, which is preparing human trials for its lead multiple sclerosis therapy while expanding its IP moat across three continents.
The granted patent protects BioNxt’s method of administering anticancer compounds via sublingual thin-film formats—a delivery mechanism that bypasses gastrointestinal degradation. This approach could significantly improve treatment adherence for chronic autoimmune conditions where current therapies require frequent injections or infusions.
CEO Hugh Rogers told investors: “This European validation confirms our position as innovators in alternative drug delivery. With patent prosecution progressing in other major jurisdictions, we’re positioned to capture value across both therapeutic and geographic markets.”
BioNxt’s platform technology shows particular promise in multiple sclerosis, where its BNT23001 candidate aims to reformulate Cladribine—a therapy with proven efficacy but historically limited by administration challenges. Industry analysts note sublingual delivery could reduce dosing frequency while maintaining therapeutic blood concentrations, potentially creating a $1B+ market opportunity in MS alone.
Commercialization Horizon
The company has initiated national phase patent filings across 12 jurisdictions, including the United States and Japan. Parallel regulatory work continues on BNT23001, with human bioequivalence studies slated for Q3 2025. Success in these trials could enable BioNxt to pursue accelerated approval pathways in Europe under existing EMA guidelines for reformulated therapies.
Pipeline Expansion
Beyond MS, BioNxt is adapting its sublingual platform to deliver disease-modifying therapies for lupus nephritis and rheumatoid arthritis. Preclinical data suggests the technology could enhance bioavailability of biologic agents—a holy grail for oral delivery of large-molecule drugs.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. develops precision drug delivery systems targeting the $1.5T global pharmaceutical market. Its pipeline includes transmucosal films, transdermal patches, and enteric-coated tablets designed to improve efficacy and patient compliance across neurology, immunology, and metabolic disorders. The company maintains R&D facilities in Canada and Germany, with strategic focus on European commercialization pathways.
View the original press release on ACCESS Newswire
Key Questions
How does sublingual delivery improve autoimmune treatments?
The thin-film format bypasses first-pass metabolism, potentially increasing drug bioavailability while enabling precise dosing without injections.
What’s the significance of European patent approval?
Provides 20-year market exclusivity across 39 EPO member states, creating partnership opportunities with EU-based pharma companies.
When might BNT23001 reach patients?
Pending successful bioequivalence data, BioNxt could file for EMA conditional approval in late 2026 under existing Cladribine regulatory frameworks.
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