Crohn’s disease (CD) is a serious and lifelong chronic inflammatory bowel disease (IBD) which can affect any part of the gastrointestinal tract (GIT) but most commonly occurs in the lower part of the ileum, caecum and ascending colon.

Selective neutralisation of TNFα by antibodies is established as an effective and transformative treatment for CD. Three anti- TNFα antibodies: infliximab, adalimumab and certolizumab are currently used clinically for the treatment of CD.

These monoclonal antibodies (mAbs) must be administered parenterally requiring either a hospital visit which is inconvenient for the patient, or multiple injections. This mode of administration can be painful and can also result in unwanted systemic side effects associated with long term systemic suppression of TNFα. An oral antibody delivered locally to the site of inflammation in IBD could therefore have major benefits: ease of administration, preservation of efficacy, and the potential to minimise unwanted systemic side effects.

To date, other than protein replacement products, very few oral peptides have been commercialised, which reflects the significant challenge of oral biologic delivery.