Mr. Wolfgang Probst reports
BIONXT ADVANCES SEMAGLUTIDE ODF PROGRAM INTO ACTIVE PHARMACEUTICAL DEVELOPMENT
Bionxt Solutions Inc.'s semaglutide oral dissolvable film (ODF) program has entered the active pharmaceutical development phase in collaboration with German drug development partner Gen-Plus GmbH.
The advancement represents a significant strategic milestone for Bionxt as the company applies its expertise in sublingual thin-film drug delivery systems beyond neurological and autoimmune diseases into the rapidly growing global GLP-1 therapeutics market.
Applying Bionxt's thin-film expertise to the rapidly growing GLP-1 market
Semaglutide is the active pharmaceutical ingredient used in leading GLP-1 therapies for obesity, metabolic disorders and Type 2 diabetes -- one of the fastest-growing and most commercially significant sectors in global health care. Demand for convenient, patient-friendly treatment options continues to accelerate as GLP-1 therapies become increasingly mainstream across chronic disease management and weight-loss applications.
Bionxt is developing a sublingual thin-film formulation designed to dissolve rapidly in the oral cavity, supporting a convenient, portable and needle-free delivery approach for GLP-1 therapies. The program leverages the company's extensive experience in oral dissolvable film development, formulation science and sublingual drug delivery technologies established through previous ODF programs and proprietary platform expertise.
The company believes next-generation drug delivery technologies capable of improving convenience, portability and patient adherence may become increasingly important as chronic disease therapies continue shifting toward patient-centric treatment models.
Moving from concept to active pharmaceutical development
The first phase of the semaglutide development program is expected to span approximately six to nine months and focuses on formulation development, development of analytical methods, analytical characterization, compatibility testing and proof-of-concept evaluation activities.
Initial work completed or currently under way includes theoretical formulation studies for sublingual semaglutide administration, sourcing of active pharmaceutical ingredients and excipients, development of analytical methods for raw materials and finished formulations, compatibility testing of formulation components, and placebo thin-film studies evaluating dissolution and film performance characteristics.
Proof-of-concept studies are expected to begin following receipt of semaglutide API (active pharmaceutical ingredient) materials anticipated later this year. Successful early-stage results may support future formulation optimization, scale-up activities and potential intellectual property development.
Extending Bionxt's thin-film technology into the future of chronic disease treatment
"Advancing our semaglutide program into active pharmaceutical development is an important step in the evolution of Bionxt from a single-product story into a broader drug delivery platform company," said Hugh Rogers, chief executive officer of Bionxt Solutions. "Our team has built significant expertise in oral dissolvable film formulation, sublingual delivery systems and pharmaceutical development through previous ODF programs. We believe this experience creates a strong foundation to evaluate additional high-value therapeutic opportunities such as semaglutide."
Bionxt's proprietary ODF platform focuses on rapidly dissolving sublingual drug delivery systems designed to improve ease of administration and patient accessibility while potentially addressing limitations associated with traditional oral dosage forms and injectable therapies.
The company's lead ODF development program for cladribine has already demonstrated encouraging preclinical pharmacokinetic and tolerability results and is advancing toward human bioequivalence studies for multiple sclerosis treatment. Bionxt believes the technological and manufacturing expertise developed through its cladribine program creates a strong operational foundation for future ODF candidates across multiple therapeutic indications.
Positioning for the future of patient-centric drug delivery
Bionxt's broader platform strategy is focused on developing patient-friendly, needle-free pharmaceutical delivery technologies designed to improve convenience, portability and treatment adherence. The company believes rapidly dissolving sublingual films may offer significant advantages for certain patient populations by simplifying administration and reducing barriers associated with conventional dosage forms.
As global health care continues shifting toward patient-centric treatment models, Bionxt believes advanced delivery technologies capable of combining pharmaceutical performance with convenience and accessibility may represent a significant long-term market opportunity.
About Bionxt Solutions Inc.
Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumours while reducing side effects.
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 health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and the OTC Markets under the symbol BNXTF and trades in Germany under WKN: A3D1K3.
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