BioNxt Solutions Inc.
4.3.2024 09:08:21 CET | ACCESS Newswire | Press release
VANCOUVER, BC / ACCESSWIRE / March 4, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that the comparative pharmacokinetic ("PK") study for its oral dissolvable film ("ODF") based proprietary Cladribine product for the treatment of Multiple Sclerosis ("MS") has been completed. Results will be reported by the Company when available. The PK study closely follows the unanimously successful results of the ODF Cladribine toxicity study, announced February 7, 2024.
BioNxt is developing a proprietary hybrid-generic ODF Cladribine dosage form, directed at the MS market. Cladribine tablets are approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us.
The comparative PK study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) Cladribine. Blood testing and analysis was carried out pre-dose and at up to six time points after administration using blood aliquots.
BioNxt has accelerated its Cladribine ODF program in a priority manner with GMP product development and batch production planned for Q1 and Q2 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Q2 2024.
The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
BioNxt's wholly owned subsidiary is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global pharmaceutical drug delivery market size was valued at USD 1,525 billion in 2022 and expected to surpass approximately USD 2,047 billion by 2030.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
BioNxt Solutions Inc.
Hugh Rogers, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422
Cautionary Statement Regarding "Forward-Looking" Information
Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as "expects", "intends", "is expected", "potential", "suggests" or variations of such words or phrases, or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company's control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.
SOURCE: BioNxt Solutions Inc.
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
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
U.S. Polo Assn. Expands Collegiate Partnership Program to Record 70 Teams for 2026 Season5.3.2026 13:00:00 CET | Press release
WEST PALM BEACH, FLA. / ACCESS Newswire / March 5, 2026 / U.S. Polo Assn., the official sports brand of the United States Polo Association (USPA), proudly announces the continued expansion of its Collegiate Partnership Program (CPP) for the 2026 season and academic year. Now in its eighth consecutive year, the program reaches a historic milestone by supporting 70 collegiate teams across 31 universities nationwide, the largest number of teams ever participating in the program.U.S. Polo Assn.'s Collegiate Partnership Program featuring the California Polytechnic State University Women's and Men's Polo Teams Photo Credit: California Polytechnic State University Polo Teams U.S. Polo Assn. will outfit hundreds of student-athletes from coast to coast, including small private and large public institutions, Ivy League Universities, and Historically Black Colleges and Universities (HBCUs). The CPP supports 35 women's and 35 men's teams, reinforcing U.S. Polo Assn.'s long-standing commitment to g
British Library Selects Preservica for Large-Scale Digital Preservation Program4.3.2026 15:00:00 CET | Press release
OXFORD, UK AND BOSTON, MA / ACCESS Newswire / March 4, 2026 / Preservica, the leader in AI-powered Active Digital Preservation™, today announced that it has been selected by the British Library to provide a Digital Preservation Repository solution and project implementation services to support the long-term preservation and management of the Library's extensive, petabyte- scale digital collections. Following a formal procurement and evaluation process, Preservica will deliver a secure, cloud-based Digital Preservation platform to support the continuous acquisition, management, and long-term preservation of the Library's diverse and expanding digital collections - including e-books, e-journals, sound recordings, UK websites, eTheses, digitised heritage materials and more - strengthening its ability to safeguard digital content for future generations. "Robust and secure Digital Preservation is essential for the effective custodianship, management and long-term readability of modern digit
Accu-Time Systems Announces Strategic Integration with Connecteam for Seamless Workforce Management4.3.2026 15:00:00 CET | Press release
The collaboration brings enterprise-grade stride80 time clocks to the Connecteam ecosystem, offering businesses a unified solution for high-accuracy attendance and real-time data sync. BOSTON, MASSACHUSETTS / ACCESS Newswire / March 4, 2026 / Accu-Time Systems (ATS), a leading provider of employee time collection solutions, today announced a strategic partnership with Connecteam, the all-in-one platform for managing distributed workforces. This collaboration integrates Connecteam's workforce management system with Accu-Time Systems' stride80 employee time clocks-delivering a unified, accurate, and secure way to collect employee time for payroll processing. Through this integration, employee punches recorded on stride80 time clocks are automatically transmitted to Connecteam's time tracking system in real time. The result is a streamlined data flow that eliminates manual entry, reduces payroll errors, and saves organizations valuable administrative time. "By integrating Connecteam's pla
Formerra Appoints Tom Kelly as Chief Executive Officer4.3.2026 14:00:00 CET | Press release
CLEVELAND, OHIO / ACCESS Newswire / March 4, 2026 / Formerra, LLC ("Formerra"), a leading distributor of engineered thermoplastic resins, additives, elastomers, and other specialty materials, today announced the appointment of Tom Kelly as Chief Executive Officer ("CEO"). A seasoned executive with over 30 years of specialty and engineered materials experience, Tom is known for leading teams to drive differentiated growth and building high-performing organizations set up for long-term success. The former CEO, Cathy Dodd, will stay on as Special Advisor to the Board and will remain an investor in the Company. Tom brings extensive commercial, supply chain, and distribution experience with a strong background in scaling global enterprises in the engineered materials sector. After previous roles at Cabot Microelectronics and Chemtura, Tom's most recent role was Senior Vice President of Engineered Materials at Celanese, where he led key commercial and operational initiatives across engineere
New GTDC Research Details Distribution's Influence on AI, Cloud and Hyperscaler Sales and Adoption3.3.2026 16:00:00 CET | Press release
IT distributors have become digital ecosystem orchestrators that unify cloud, AI, hyperscaler, and subscription-based business models. Distribution significantly accelerates vendor growth while reducing risk, allowing suppliers to scale efficiently, expand partner bases, enter new markets and mitigate financial and operational liabilities. Digital platforms are creating a new GTM "operating system". These systems offer end-to-end digital commerce and intelligence layers to manage procurement, billing, lifecycles and analytics. TAMPA, FL / ACCESS Newswire / March 3, 2026 / The Global Technology Distribution Council (GTDC), the world's largest consortium of technology distributors, has released a new research report, Distribution: The Digital Force Multiplier. Developed by CommCentric Solutions, this study examines how IT distribution has transformed and continues to evolve into a critical enabler of cloud, artificial intelligence (AI), hyperscaler and platform-driven business models acr
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