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
Fidelity Investments Upgrades FINOS Membership to Platinum, Reinforcing Its Strategic Commitment to Open Source Collaboration in Financial Services11.2.2026 15:00:00 CET | Press release
Following its leadership in launching Fluxnova, Fidelity's appointment to the FINOS Governing Board underscores the growing recognition of the ROI of open source for all market participants NEW YORK CITY, NY / ACCESS Newswire / February 11, 2026 / The Fintech Open Source Foundation (FINOS), the foundation of open innovation in financial services, today announced that Fidelity Investments has upgraded its FINOS membership to Platinum, reflecting Fidelity's deepening strategic commitment to open source collaboration, industry interoperability, and the responsible adoption of emerging technologies such as AI across regulated financial services. The membership upgrade builds directly on Fidelity's role in the formation of Fluxnova, a FINOS-hosted open source orchestration platform created to address critical industry needs around workflow automation, vendor independence, and long-term infrastructure sustainability. Fidelity spearheaded the project's contribution into FINOS, helping establi
U.S. Marine Corps Selects GA-ASI for MUX TACAIR Collaborative Combat Aircraft Program10.2.2026 21:00:00 CET | Press release
GA-ASI's YFQ-42A Platform to Support Next-Generation Expeditionary Air Operations SAN DIEGO, CALIFORNIA / ACCESS Newswire / February 10, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) was competitively selected by the U.S. Marine Corps (USMC) for evaluation in the Marine Air-Ground Task Force Uncrewed Expeditionary Tactical Aircraft (MUX TACAIR) Collaborative Combat Aircraft (CCA) program. The agreement integrates GA-ASI's expertise in autonomy and uncrewed aircraft systems with a government-provided mission package, usingthe YFQ-42A platform as a surrogate to evaluate integration with crewed fighters. The contract initiates integration of a Marine Corps mission kit into the YFQ-42A surrogate platform for assessment within the Marine Air Ground Task Force (MAGTF). The USMC contract includes the rapid development of autonomy for the government-supplied mission kit - a cost-effective, sensor-rich, software-defined suite capable of delivering kinetic and non-kinetic effects -
Changing Your Dog's Diet May Help the Planet More Than Changing Your Own, Study Finds10.2.2026 17:30:00 CET | Press release
LONDON, UK / ACCESS Newswire / February 10, 2026 / Diets high in meat, eggs, and dairy products incur significant environmental costs. But a new study has revealed that, in many cases, switching your dog to a more sustainable diet may have a bigger impact on the planet and farmed animals than changing your own diet. The research, published in the journal Animals by veterinary Professor Andrew Knight, found that the average dog consumes around 13 farmed land animals annually within its diet, compared with nine for the average person--a difference of roughly 40%. This gap exists largely because a greater proportion of a typical dog's dietary energy comes from animal-based ingredients--about 34%--compared to around 19% for people. These figures represent global averages and vary by country. In high-income nations such as the United States, consumption is higher across the board. There, an average person consumes 24 farmed land animals annually, compared with 20 for a dog--a smaller differ
Reco Raises $30M B Round for a Total of $85M to Meet Rapidly Growing Demand for AI SaaS Security Among Enterprises10.2.2026 16:30:00 CET | Press release
After growing ARR by 400% in 2025, Reco secures new backing months after its last funding to secure AI SaaS usage NEW YORK CITY, NEW YORK / ACCESS Newswire / February 10, 2026 / Reco, a leader in securing AI SaaS environments, today announced a $30 million Series B funding round led by Zeev Ventures, with participation from all existing investors including Insight Partners, boldstart ventures, while adding new corporate investors Workday Ventures, TIAA Ventures, S Ventures, and Quadrille Capital. The new funding comes less than 10 months after Reco's previous raise to meet the exponential demand to discover and secure AI SaaS at any modern enterprise. The round follows another year of exceptional growth for Reco. After growing 500% year-over-year in 2024, the company scaled an additional 400% in 2025 on a significantly larger base, driven by a sharp increase in enterprise AI adoption and the rapid rise of shadow AI, where 71% of knowledge workers now use AI tools without IT approval an
Logista Strator and Shekel Sign an Agreement to Bring Innovendi Elite to Spain - The Autonomous Sales Solution That Boosts Sales10.2.2026 14:05:00 CET | Press release
The goal is to put a technology in the hands of tobacconists and the Spanish retail sector to open new revenue channels. MADRID, ES / ACCESS Newswire / February 10, 2026 / Logista Strator, the technology platform specialized in retail management and part of Logista, has reached a strategic agreement with Shekel, developer of WeightAI™ technology and manufacturer of Innovendi Elite, for its distribution in Spain and Portugal. The companies will present the Innovendi Elite at the Hospitality Innovation Planet (HIP) trade fair in Madrid from February 16-18, 2026. Innovendi Elite is a next-generation smart fridge that redefines the future of vending experience: an advanced autonomous retail solution that combines patented weighing technology with artificial intelligence to deliver a completely frictionless shopping experience. Customers pay by card or app, open the cooler, select their products, and continue on their way without waiting. Its ability to operate in continuous mode and adapt
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