BioNxt Solutions Reports Progress on BNT23001 Development for Multiple Sclerosis Treatment
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
Cyara Appoints Sushil Kumar as CEO to Extend Enterprise AI Customer Experience (CX) Leadership8.12.2025 22:30:00 CET | Press release
Visionary AI and cloud executive with proven record of building and scaling enterprise platforms to lead the next phase of innovation and global expansion for the CX assurance market leader. AUSTIN, TX / ACCESS Newswire / December 8, 2025 / Cyara, the global leader in AI-powered customer experience (CX) assurance, today announced the appointment of Sushil Kumar as its new Chief Executive Officer. His appointment underscores Cyara's commitment to accelerating enterprise AI CX innovation and elevating customer experience by enabling more reliable, responsive, and trustworthy interactions across every channel. Sushil will build on the strong foundation laid by outgoing CEO Rishi Rana. Sushil brings entrepreneurial vision and enterprise-scale leadership to Cyara. He has focused his career on building category-defining AI, DevOps, and cloud platforms, both as a founder and as a leader of large global organizations. Most recently, he was Co-Founder and CEO of RelicX.ai, a generative AI test
AI21 Labs and Fnac Darty, Partner to Drive Retail AI Transformation8.12.2025 09:00:00 CET | Press release
Fnac Darty selects AI21 as a strategic AI partner to tackle retail's most complex challenges, starting with After-Sales service, with Maestro, the leading AI orchestration platform. PARIS, FR AND TEL AVIV, IL / ACCESS Newswire / December 8, 2025 / AI21 labs, a frontier AI developer and a global leader in enterprise AI, announced a strategic partnership with Fnac Darty, one of Europe's leading retailers with a network of both online and physical stores. The collaboration marks a flagship initiative in Fnac Darty's long-term growth strategy and positions AI21 as a strategic partner for the rollout of AI across the company's operations. The partnership supports Fnac Darty's recently announced "Beyond Everyday" strategic plan, which focuses on accelerating the company's transition from a product-based model to services and subscriptions, with After-Sales at the heart of this evolution. The first use case will focus on after-sales service, a mission-critical area for Fnac Darty and a corner
The 13th GLA Global Logistics Conference Successfully Concludes in Bangkok, Thailand5.12.2025 16:00:00 CET | Press release
More than 2,000 logistics leaders from 130+ countries convene in Thailand to advance peace, digital innovation and trustworthy cooperation in global supply chains. SHENZHEN, CN / ACCESS Newswire / December 5, 2025 / The 13th GLA Global Logistics Conference was successfully held in Bangkok, Thailand from November 7-10, 2025, providing a prestigious international platform for business cooperation in the global logistics sector. Co-organized by the Global Logistics Enterprises Federation (GLEF) and the GLA Global Logistics Alliance, the event centered around the theme "Peaceful Prosperity, Digital Innovation, Trustworthy Cooperation." The conference brought together over 2,000 logistics professionals and industry leaders from more than 130 countries, fostering a unique environment for collaboration and knowledge exchange. With its exceptional industry influence and capacity for cross-border resource integration, GLA continues to emerge as a pivotal force in driving global supply chain inn
OMP's AI-driven Unison Planning(TM) Platform Enhances Supply Chain Agility for McCormick & Co.3.12.2025 15:00:00 CET | Press release
ATLANTA, GEORGIA / ACCESS Newswire / December 3, 2025 / OMP is helping McCormick & Co., the global leader in flavor, with an AI-driven and autonomous operational planning initiative. This partnership enables McCormick to manage both assembly-to-order (ATO) and make-to-stock (MTS) production within the Unison PlanningTM platform. The initiative tackles key challenges, including balancing ATO and MTS production on shared lines, improving inventory projections through quality-based stock releases, and managing capacity amid fluctuating demand. Addressing these challenges requires close collaboration across regions with North American and EMEA teams working in parallel, and seamless integration of SAP with the operational planning functionality within Unison Planning™. The first implementations will roll out in Canada and the United States before expanding to the EMEA and APAC regions. Through its partnership with OMP, McCormick is implementing autonomous, decision-centric planning powered
Oman's 10-Year Golden Residency Program Attracts Global Investors Seeking Stability and Long-Term Access3.12.2025 14:00:00 CET | Press release
Built for investors who value certainty, global access, and long-term confidence. MUSCAT, OM / ACCESS Newswire / December 3, 2025 / Three months after its introduction, Oman's 10-Year Golden Residency is emerging as one of the region's most compelling long-term residency pathways, attracting rising interest from investors, entrepreneurs, and internationally mobile families seeking stability, transparent regulation, and strategic access to high-growth markets. The programme-launched under Oman Vision 2040-offers a structured framework for investors wishing to establish deeper roots in a country positioning itself as a secure and globally connected economic hub.Prosperity and Liveability in Oman.jpg A contemporary Omani setting featuring growth, safety, and quality-of-life elements that define the country's reputation for prosperity and liveability. The Golden Residency grants eligible applicants long-term residency in return for a minimum investment of USD 520,000 across seven clearly d
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