- The pill is enteric coated to provide release of antibody in the colon
- Once in the colon, excipients in the core protect the antibody from microbiome derived enzymes
- High luminal antibody levels combined with active receptors transport the antibody into the mucosa and lamina propria
- Hope for patients in the future to switch to a pill rather than take frequent injections for lifelong chronic diseases
Oral delivery of biologics, let alone monoclonal antibodies, is still considered as the ‘holy grail’ in biopharmaceutical industry, although very few products have reached the market. The primary reason has been the plethora of barriers presented by the human gastrointestinal (GI) tract that have proven to be very challenging to be overcome till date.
Intract has been developing a platform technology called Soteria® that involves targeted delivery of antibodies (IgG, Fab, VHH domain) to the colon using commercially validated Phloral® enteric coating that is applied on the outside of the pill. Upon release of the antibody in the colon, certain excipients that have been carefully screened and selected, provide protection against microbiome derived protease degradation and subsequently active receptors lining the colonic epithelium allow effective transcytosis of antibody into the mucosa and lamina propria to achieve sustained and high levels of antibody in the tissue with potential for absorption into the systemic circulation via lymphatic system transportation.
The platform technology provides hope for patients to be able to swallow antibody in the form of a safe and simple pill and rid them of having to take frequent and lifelong injections to treat/prevent relapse of chronic diseases of the GI tract such as inflammatory bowel disease, pathogenic infections and bowel cancer which are currently treated with high dose injections of antibodies.