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The quest for technologies that permit oral delivery of macromolecules has remained unfulfilled despite many discovery and formulation attempts. Trinity Biosystems' rational and scientifically rigorous approach to the design of orally delivered bio-therapeutic macromolecules works cooperatively with the natural physiology of the body by taking advantage of a normal receptor-mediated biological process by which large molecules are transported across mucous membranes.
Macromolecules are large, complex molecules that comprise such drug classes as therapeutic proteins, peptides and antibodies. They are used to treat many serious human diseases, including metabolic disorders, cancer and immunological disorders. While therapeutically valuable, the administration of large molecules has been mainly limited to systemic delivery through infusion and injection. Their limitations are due to size; they are too large to be absorbed by membranes in the gastrointestinal tract and therefore cannot enter the circulation after oral administration. Trinity is overcoming this challenge by creating orally delivered bio-therapeutic macromolecules that are designed to remain intact through the digestive system and that can be absorbed in the intestinal environment.
Trinity's proprietary platform is called the TriPex™ system. The TriPex™ system utilizes a specific and efficient natural biological transport mechanism: a receptor-mediated transcellular pathway that allows large molecules to enter the body. This pathway allows passage of Trinity's proprietary fusion proteins through the mucosal epithelium and delivery of the therapeutic payload into the blood. The main value of the TriPex™ system is its ability to overcome the absorption barrier, allowing efficient absorption of intact molecule from the intestine and delivery to target tissue.
Trinity's approach is distinctly different from other macromolecule delivery technologies which disrupt the integrity of the intestinal epithelium by opening the inter-cellular tight junctions or permeabilizing the cellular membranes. In contrast, Trinity's platform leverages a natural epithelial cell pathway to carry proteins, peptides and other macromolecules across intact mucosae, thereby achieving drug absorption.
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