Plant-Based Oral Therapeutics: A Conceptual Framework for an Integrated Biotherapy Modality

This manuscript presents a conceptual framework for plant-based oral therapeutics (PBOTs), defined as therapeutic molecules expressed within plant matrices and administered orally within those matrices to engage gut-mediated biological pathways.

The framework integrates advances in plant molecular engineering, oral bioencapsulation, and systems-level disease biology to outline a novel biotherapy modality for chronic diseases characterised by dysregulated metabolic and inflammatory signalling, referred to here as metabolic-inflammatory diseases (MIDs).

We describe the mechanistic rationale underlying this approach, including plant-based expression of pharmacological molecules, matrix-mediated stability and delivery, and pathway-level biological engagement. Potential applications are discussed with a focus on chronic kidney disease and related cardiometabolic conditions.

In addition, the manuscript outlines key translational considerations, including dose control under biological variability, structural and biophysical characterisation, regulatory positioning, and longitudinal evaluation strategies for chronic disease contexts.

This work is intended as a conceptual and mechanistic contribution to the emerging field of plant-based oral biotherapeutics. Experimental validation of programmable expression, dosing precision, and clinical efficacy remains an essential next step.