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
Loar Holdings Inc. Announces Date and Time for Third Quarter 2026 Earnings and Conference Call7.10.2026 22:05:00 CEST | Press release
WHITE PLAINS, NY / ACCESS Newswire / October 7, 2026 / Loar Holdings Inc. (NYSE:LOAR) will report Q3 2026 earnings before the market opens on Thursday, November 5, 2026. A conference call will follow at 11:00a.m. Eastern Time. To participate in the call telephonically please dial +1 877-407-0670 / +1 215-268-9902. International participants can find a list of toll-free numbers here. A live audio webcast will also be available at the following link as well as through the Investor section of Loar Holdings website: https://ir.loargroup.com The webcast will be archived and available for replay later in the day. About Loar Holdings Inc. Loar Holdings Inc. is a diversified manufacturer and supplier of niche aerospace and defense components that are essential for today's aircraft and defense systems. Loar has established relationships across leading aerospace and defense original equipment manufacturers and Tier Ones worldwide. Contact Ian McKillop Loar Holdings Inc. Investor Relations IR@loa
Surmodics Launches IOL Cartridge Coating Automation Center in Horsham7.10.2026 21:30:00 CEST | Press release
HORSHAM, PA / ACCESS Newswire / October 7, 2026 / Surmodics, a provider of surface technologies and performance coatings for the medical device industry, today announced at the opening of the American Academy of Ophthalmology annual meeting in New Orleans the launch of its IOL Cartridge Coating Automation Center at its Horsham, Pennsylvania site just outside Philadelphia. "The delivery system for an intraocular lens (IOL) combines precision injection-molded parts with a specifically selected lubricious, biofriendly coating," said Chip Hance, CEO of Surmodics. "As IOL manufacturers increasingly seek automated assembly and modern biomaterial formulations, our Automation Center provides automated coating processes designed for efficient production throughout the product lifecycle." The center brings together advanced hydrophilic coating technology, decades of IOL cartridge application expertise, precision coatings processes and automation capabilities in a manufacturing platform developed
Nevada Court Lifts Restriction, Clearing EESystem to Share Recording of November 2024 Meeting7.10.2026 15:00:00 CEST | Press release
LAS VEGAS, NV / ACCESS Newswire / October 7, 2026 / On September 25, 2026, Judge Erika Mendoza of the Eighth Judicial District Court of Nevada, Clark County, entered a written order denying Jason Shurka's motion for a preliminary injunction and granting Michael Bertolacini's motion to dissolve a temporary restraining order that had barred public dissemination of a recording of a November 14, 2024 meeting. The ruling was issued in Case No. A-25-910216-B, Department XXVII, a matter brought by Energy Enhancement System LLC ("EESystem"), Michael Bertolacini and Dr. Sandra Rose Michael against Jason Shurka and other defendants. In its written order, the court stated that its earlier suggestion that Jason Shurka's consent was needed to share the recording was incorrect, and that the restriction was dissolved as of the September 2, 2026 hearing. According to the order, the meeting was recorded on a cellphone by Manny Shurka, Jason Shurka's father, and Jason Shurka produced that recording in t
Steelcase 2025 Impact Report Highlights Progress in Reducing Emissions and Strengthening Communities7.10.2026 15:00:00 CEST | Press release
GRAND RAPIDS, MI / ACCESS Newswire / October 7, 2026 / Steelcase, a global design and thought leader in the world of work, today released its 2025 Impact Report, "Our Work Toward Better Futures." Steelcase recorded reductions in scope 1 and 2 emissions by 33% from its 2019 baseline and activated 324 Better Futures Community partnerships across 38 locations. The report details how Steelcase members, customers and partners are helping communities thrive and moving the organization closer to net zero. "Our commitments to people and the planet help focus the choices we make, the partnerships we build and the value we create," said Megan Blazina, senior vice president, international, digital and strategy at Steelcase, who also leads sustainability and social impact. "The progress in this report reflects how we're turning those commitments into action." As Steelcase looks ahead as a new part of HNI Corporation, the companies' shared focus on the wellbeing of people and the planet provides a
PostSig Expands Enterprise Platform for Financial and Operational Control7.10.2026 15:00:00 CEST | Press release
SAN FRANCISCO, CA / ACCESS Newswire / October 7, 2026 / PostSig today introduced a significant expansion of its enterprise platform, giving Finance, Procurement, Market Data and Operations teams a shared foundation for managing commercial performance. The expansion follows PostSig being named Best Data Governance Solution in WatersTechnology's 2026 Inside Market Data & Inside Reference Data Awards and its first enterprise deployment with data consultancy CJC, which manages market data for a London multi-asset broker. Pricing schedules, service orders, product inventories and entitlements change over time. When teams manage those records separately, they may see individual values but cannot reliably determine which one applies, why it changed, or how the change should affect spend. "Commercial commitments do not stop at the document," said Hendrik Bartel, CEO and Co-Founder of PostSig. "They show up in products, pricing, invoices, entitlements, usage, and accountability. PostSig connect
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