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
Formerra Receives 2026 Eaton Supplier Excellence Award3.9.2026 16:45:00 CEST | Press release
Recognition places Formerra among several dozen honorees from a supplier network of more than 30,000. ROMEOVILLE, IL / ACCESS Newswire / September 3, 2026 / Formerra, a leader in performance materials distribution, was recognized for its partnership at Eaton's 2026 Global Supplier Conference & Excellence Awards, held Thursday, August 27 in Beachwood, Ohio. Formerra was one of only 30 suppliers recognized with Eaton's Supplier Excellence Award from among the company's global network of more than 30,000 supplier partners. Eaton grants the Supplier Excellence Award to suppliers that exceed expectations through exceptional performance, innovation, and contributions to growth. Formerra serves as Eaton's preferred plastics distribution partner, a role built through disciplined execution and engagement across Eaton's corporate organization and manufacturing sites. While the partnership began over 15 years ago in North America, it now extends into Asia, Europe, and the Middle East, where Forme
DistillerSR Joins European MedTech Consortium to Digitalize Medical Device and IVD Conformity Assessments3.9.2026 16:00:00 CEST | Press release
€4 million European-funded DIGICAP project brings together 19 organizations to replace document-based conformity assessments with machine-readable data. DistillerSR named one of five technology providers building the framework. OTTAWA, ON / ACCESS Newswire / September 3, 2026 / DistillerSR, the market leader in AI-enabled literature review automation and evidence management, today announced its participation in DIGICAP (DIGItalisation of the Conformity Assessment Process), a €4 million European initiative uniting 19 organizations across 12 EU countries to digitalize how medical devices and in vitro diagnostics are certified for the European market. The project is funded under Horizon Europe, the world's largest multinational research and innovation program, with a budget of €95.5 billion for the 2021-2027 period. DistillerSR is one of five regulatory technology providers selected to support the project, alongside Veeva, MEDDEVO, AUREVIA and Hardian Health. The company will work in the
U.S. Polo Assn. Marks Continued Success as Title Sponsor of the 2026 Pacific Coast Open3.9.2026 13:00:00 CEST | Press release
Historic Championship Brings Together Elite Competition, California Lifestyle, and the Authentic Spirit of the Sport of Polo SANTA BARBARA, CA / ACCESS Newswire / September 3, 2026 / U.S. Polo Assn.®, the official sports brand of the United States Polo Association (USPA), celebrated the conclusion of the 2026 U.S. Polo Assn. Pacific Coast Open, held August 14-30 at the renowned Santa Barbara Polo & Racquet Club in Carpinteria, California. As one of the oldest polo tournaments in the world and the most prestigious championship in the Western United States, the Pacific Coast Open once again delivered world-class competition while highlighting the enduring connection between sport, style, and community. 2026 U.S. Polo Assn. Pacific Coast Open Winners, Klentner Ranch, on stage with trophy; Photo Credit: Michelle Lauren This year marked the second time U.S. Polo Assn. served as Title Sponsor of the Pacific Coast Open and the ninth consecutive year partnering with the Santa Barbara Polo & Ra
CubeLogic Launches a New Generation of Credit Risk Technology with RiskCubed Version 123.9.2026 11:00:00 CEST | Press release
The most significant technology shift in CubeLogic's history - delivering real-time performance, natural language reporting, and AI built directly into the platform. LONDON, UK / ACCESS Newswire / September 3, 2026 / CubeLogic, the leading provider of enterprise risk and compliance software for trading organisations across the energy and commodities sector, today launched Version 12 (V12) of its RiskCubed platform - bringing real-time, AI-powered credit risk management to a market that has long depended on overnight processing. Built on modern, cloud-native foundations, V12 re-architects how RiskCubed stores data, delivers reporting, runs margining and scales to meet demand. For credit teams, that changes the working day as well as the technology behind it: exposure positions can be reviewed as they update rather than waiting on a batch, and reports that previously required a specialist can be built in the moment. "We are excited to partner with our clients in developing the next gener
Eudia and Harbor Partner to Accelerate AI Transformation for Enterprise Legal Teams1.9.2026 20:25:00 CEST | Press release
Harbor's trained industry experts will deliver advisory, implementation, training, and adoption enablement, helping enterprise legal departments deploy Eudia's augmented intelligence platform successfully at scale PALO ALTO, CA / ACCESS Newswire / September 1, 2026 / Eudia, the augmented intelligence platform for legal, contracting, and compliance work across the enterprise, today announced a strategic partnership with Harbor, the leading provider of professional and technology services to the legal industry. Harbor's industry experts, who guide digital transformation for close to 600 corporate law departments and more than 80% of Global 200 law firms, will help enterprise legal teams adopt Eudia's platform and deploy it successfully at scale. Enterprise legal departments are under growing pressure to show results from AI. The challenge is rarely the technology alone: institutional knowledge sits scattered across contracts, policies, and a small number of experienced professionals, and
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