BioNxt Solutions Reports Progress on BNT23001 Development for Multiple Sclerosis Treatment
9.12.2024 03:05:00 CET | ACCESS Newswire | Press release
VANCOUVER, BC / ACCESSWIRE / December 9, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in advanced drug delivery systems, has achieved key milestones in the development of BNT23001, its proprietary sublingual thin-film (OFD) formulation of Cladribine for the treatment of Multiple Sclerosis (MS). These achievements in 2024 lay the groundwork for clinical trials and regulatory submissions in 2025, reinforcing BioNxt's commitment to advancing patient-centric therapeutic solutions.
2024 Milestones: Establishing a Strong Foundation for Cladribine Thin-Film Development
Preclinical Success: BNT23001 demonstrated high absorption rates of Cladribine through sublingual delivery in pharmacokinetic (PK) studies conducted in animal models. These studies confirmed the product's bioequivalence to the originator therapy, Mavenclad®, and validated the thin-film's rapid absorption and safety profile. Toxicity studies further demonstrated no adverse local effects, highlighting the viability of the sublingual delivery approach.
Advancements in Manufacturing: BioNxt successfully transferred the BNT23001 production process to its GMP-certified manufacturing partner, Gen-Plus GmbH & Co KG in Munich (Germany), ensuring readiness for clinical batch production. This milestone supports the Company's plan to initiate clinical trials in 2025 with reliable, high-quality product supply.
Strengthened Intellectual Property Position: A favorable International Preliminary Report on Patentability (IPRP) confirmed BNT23001's novelty, inventive step, and industrial applicability, underscoring its unique value in MS treatment. The Company has initiated patent nationalization in major jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated in several regions by mid-2025.
2025 Roadmap: Advancing BNT23001 into Clinical Trials
Manufacturing Clinical Batches: BioNxt will complete GMP manufacturing and Qualified Person (QP) release of clinical trial batches in the second quarter of 2025. This step is critical for the successful initiation of human studies.
Regulatory Filings and Approvals: The Company plans to submit the Investigational Medicinal Product Dossier (IMPD) to European regulatory authorities by mid-2025, paving the way for clinical trial approval. These regulatory submissions will include data from preclinical studies and stability assessments conducted at the manufacturing site.
Clinical Study to Validate Performance: BioNxt aims to launch a pilot clinical study in the latter half of 2025. This trial will compare the efficacy, bioavailability, and safety of BNT23001 to Mavenclad®, the originator tablet product, positioning the thin-film formulation as a patient-friendly alternative.
Ongoing Patent Protection: In addition to continuing the patent nationalization process, BioNxt expects granted patents in key regions to strengthen its intellectual property portfolio and provide competitive advantages as the product moves toward commercialization.
BNT23001: Advancing Toward Clinical Validation for MS Treatment
BNT23001 offers a novel approach to MS management by addressing limitations in traditional oral therapies. Its sublingual thin-film format provides:
• Convenience: Easy-to-use and portable, ideal for patients with difficulty swallowing or active lifestyles.
• Rapid Absorption: Direct delivery through the sublingual mucosa for faster therapeutic action.
• Improved Compliance: A patient-friendly alternative designed to enhance adherence to prescribed regimens.
By delivering these advantages, BNT23001 aligns with BioNxt's mission to improve outcomes for patients living with chronic diseases like MS.
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: investor.relations@bionxt.com
Phone: +1 780-818-6422
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 BNT23001, as well as projected milestones for 2025. These statements are based on current expectations and assumptions but involve risks and uncertainties that could cause actual results to differ materially. These risks include clinical trial outcomes, regulatory delays, manufacturing challenges, intellectual property issues, market competition, and changes in laws or market conditions. The Company undertakes no obligation to update or revise forward-looking statements, except as required by law. For more information, refer to the "Risk Factors" section of the Company's filings at www.sedarplus.ca.
Trademarks: Mavenclad® is a registered trademark of EMD Serono, Inc. BioNxt Solutions Inc. is not affiliated with or endorsed by EMD Serono.
SOURCE: BioNxt Solutions Inc.
View the original press release on accesswire.com
BioNxt Solutions Inc.
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Three Polaris Projects in Mexico Selected Under the Mixed Development Program9.6.2026 01:40:00 CEST | Press release
TORONTO, ON / ACCESS Newswire / June 8, 2026 / Polaris Renewable Energy Inc. (TSX:PIF) ("Polaris" or the "Company") announced that Mexico's Secretary of Energy (Secretaría de Energía, "SENER"), and the Federal Electricity Commission (Comisión Federal de Electricidad, "CFE") have completed the first national competitive selection process under the CFE Mixed Development Program. The process was launched through a Request for Proposals ("RfP") issued in February 2026, with submitted projects evaluated in accordance with the Guidelines for Mixed Development Programs published by SENER in January 2026. On June 5, 2026, CFE and SENER announced that the final award volume exceeded the original target, with approximately 8,000 MW of projects selected for advancement under the program. As part of this award process, Polaris is pleased to announce that all three Polaris-owned projects submitted under the Mixed Development Program have been selected to advance to the final contract negotiation st
GA-ASI Announces Investments in Six Dutch Companies8.6.2026 18:00:00 CEST | Press release
New Slate of Business Partnerships Established Following the Last Blue Magic Netherlands Event SAN DIEGO, CA / ACCESS Newswire / June 8, 2026 / General Atomics Aeronautical Systems, Inc. (GA‑ASI) is deepening its footprint in the Dutch innovation ecosystem, with new investments in six Netherlands-based technology companies through its Blue Magic Netherlands (BMN) venturing initiative. These new partnerships follow the latest BMN event in Eindhoven, a fast-paced, "shark tank"-style forum in which Dutch startups and scaleups pitched breakthrough technologies directly to GA‑ASI decision makers. The most recent edition drew more than 350 attendees from across the country's aerospace, defense, and high-tech communities. Building on the success of prior events, GA‑ASI has selected six Dutch companies for new investment and collaboration. GA-ASI also is increasing its investment in Emergent Swarm, first discovered at BMN 2024. Emergent Swarm is partnering with GA‑ASI to further mature its swa
SK Tes Ireland Achieves ISO Certification Milestone and Recognized in National Digital Infrastructure Report4.6.2026 15:00:00 CEST | Press release
DUBLIN, IE / ACCESS Newswire / June 4, 2026 / SK tes, a global leader in sustainable technology lifecycle services, today announced that its Ireland facility has successfully passed audits for ISO 9001 (Quality Management), ISO 14001 (Environmental Management), ISO 45001 (Occupational Health & Safety), and ISO 27001 (Information Security Management), reinforcing its commitment to delivering consistent, high-quality, safe and sustainable services worldwide. These certifications are standard across SK tes' global network of facilities and form a core part of the company's operating model. As the newest site within this network, Ireland's certification reflects the structured commissioning process that ensures every SK tes location meets the same rigorous international standards - enabling clients to receive a consistent, secure, and compliant service experience, regardless of geography. In parallel, the Irish business has been recognized in the DII Economic Report 2026, published by Digi
Preservica takes AI for Digital Preservation to the next level with powerful new AI Editions4.6.2026 15:00:00 CEST | Press release
OXFORD, UK AND BOSTON, MA / ACCESS Newswire / June 4, 2026 / Preservica, a global leader in AI-powered Active Digital Preservation™, today announced the launch of its new AI Editions that combine human-centric AI tools with the built-in AI capacity to enable archival and records teams to quickly and safely transform their archives at scale. Developed in collaboration with the Preservica user community, the new AI Editions enable teams to process backlogs up to four times faster, meet privacy, accessibility, and FOI requirements, standardize metadata quality, accelerate content enrichment and discovery, and free time for higher-value work. With ample AI capacity included, teams can save significant time - cutting repetitive, manual work and quickly adding new value to their archives every month: Transcribe hundreds of hours of AV content or OCR thousands of scanned images or Identify PII in hundreds of thousands of documents or Standardize metadata across thousands of assets And more "S
Gedeon Richter Highlights Expanding Biosimilars Portfolio and Scientific Engagement at EULAR 20264.6.2026 14:45:00 CEST | Press release
LONDON, UK / ACCESS Newswire / June 4, 2026 / The Biotechnology Business Unit of Gedeon Richter Plc. (Richter) is present at this year's European Alliance of Associations for Rheumatology's (EULAR) European Congress of Rheumatology, underlining its role as a growing contributor to biologic therapies in Europe. The company also hosted a satellite symposium on the opening day, as part of its engagement with the rheumatology community. Richter's presence at EULAR reflects nearly two decades of focused investment following its strategic entry into biotechnology. Today, it operates a fully integrated biosimilars business with a European development and manufacturing network, including facilities in Budapest and Debrecen in Hungary, operations in Germany, and global partnerships supported by over 1,000 biotech professionals. As part of its scientific program, yesterday Richter hosted the symposium "Prevention, better than treatment - insights on inflammatory joint disease and osteoporosis" c
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom