A breakthrough from the University of Bath could mark a turning point in how we administer protein-based medications, potentially replacing injections with oral alternatives for millions of patients worldwide.
Scientists from the Department of Life Sciences at Bath have developed a novel drug delivery system that enables protein-based therapies – such as growth hormone, immunotherapies, and GLP-1 receptor agonists like Ozempic and Wegovy – to be taken orally. This innovation could transform the treatment landscape for chronic conditions by improving patient adherence and comfort while reducing the burden of injectable administration.
The Challenge with Protein Drugs
Historically, protein-based drugs have not been suitable for oral delivery. When ingested, these biologics are broken down by the digestive system before they can enter the bloodstream, rendering them ineffective. As a result, patients have relied on injections, often uncomfortable and inconvenient, particularly for those on long-term treatment regimes.
A Gut-Based Solution
Led by Professor Randy Mrsny, the Bath research team has created a platform that mimics a natural biological process used by gut bacteria. The system links the therapeutic protein to a non-toxic carrier molecule derived from a bacterium associated with cholera. This carrier binds to receptors on intestinal cells, enabling the drug to pass safely through the gut wall and into systemic circulation.
Notably, the method delivers a consistent 5–10% of the active drug – sufficient for therapeutic effect and commercial viability. Unlike previous delivery methods, this system does not damage the gut lining and is adaptable across a wide range of medications, including hormones and some cancer treatments.
Regulatory Implications and Next Steps
This breakthrough has significant implications for regulatory and market access pathways. Transitioning injectable biologics to oral formats introduces new considerations for bioavailability, dosing accuracy, and safety, but also presents clear opportunities for improved patient outcomes and lower healthcare costs.
Initial human trials could begin within two years, subject to optimisation and collaboration with pharmaceutical partners. If successful, the technology could usher in a new class of orally available biologics, setting the stage for regulatory frameworks to evolve accordingly.
Why It Matters
For pharmaceutical developers, healthcare systems, and regulators alike, innovations like this signal a future in which biologic therapies become more accessible and patient-centric. As regulators prepare to evaluate new delivery mechanisms, safety, efficacy, and manufacturing controls will be paramount.
At Woodley BioReg, we continue to monitor advancements in drug delivery technologies and support clients through the complex regulatory pathways required to bring these innovations to market.
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