Bionxt finishes semaglutide ODF proof-of-concept trials

Executive Summary

• Bionxt Solutions Inc. successfully completed proof-of-concept trials for its semaglutide oral dissolvable film (ODF) program at its German subsidiary, Vektor Pharma TF GmbH.
• The company developed first prototypes using an in-house proprietary film platform, demonstrating rapid disintegration, homogeneous quality, and favorable mechanical properties, validating the technology for complex peptide formulations.
• Development will transition to formulation optimization, stability studies, and scale-up, with a patent application expected in the coming months and preclinical animal studies targeted for early 2026.

Key Details

• Proof-of-Concept Results: Multiple proprietary film platforms were evaluated; one in-house platform achieved highly promising results, generating first prototypes of semaglutide ODF formulations.
• Prototype Characteristics: The prototypes demonstrated rapid disintegration, homogeneous film quality, good processability during manufacturing, and favorable mechanical properties.
• Strategic Validation: Results confirm the suitability of Bionxt's thin-film technology for complex peptide formulations, providing a foundation for further development.
• Intellectual Property: Bionxt is preparing to file a patent application for the semaglutide ODF in the coming months.
• Next-Stage Development: Under Vektor Pharma's supervision, efforts will focus on refining formulation to optimize performance and absorption, initiating stability studies, and advancing scale-up work.
• Timeline:
  • Development efforts expected to continue through late 2025.
  • Preclinical animal study anticipated to begin in early 2026 to evaluate pharmacological performance and suitability.
  • Investigational medicinal product (IMP) manufacturing intended to support a pilot clinical study targeted for the second half of 2026.
• Market Context: Semaglutide (marketed as Ozempic and Rybelsus) generated over $29.3 billion (U.S.) in sales in 2024. Bionxt's oral-thin-film format aims to offer a non-invasive, accessible, and compliance-friendly alternative to injectable and tablet-based options.
• Portfolio: Semaglutide is the lead candidate in Bionxt's GLP-1 ODF portfolio, which is expected to include additional GLP-1-based therapies on the proprietary thin-film platform.

Notable Quotes

• "Achieving positive proof-of-concept results with first prototypes in hand represents an important milestone for Bionxt. These results validate our approach and allow us to proceed with greater confidence as we optimize the formulation, secure intellectual property and prepare for preclinical testing." — Hugh Rogers, Chief Executive Officer