Soteria
Revolutionising treatment of inflammatory bowel disease
The challenge
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal (GI) tract, which leads to the long-term impairment of GI tract structure and function. Crohn’s disease and ulcerative colitis are two of the main IBDs, in which the immune system attacks the body, causing severe flare-ups. Although there is no cure for IBD, it can be managed with monoclonal antibody (mAb) therapies, such as the currently approved infliximab, which can help keep the immune system at bay.
Development of oral mAb products for the treatment of IBD still remains a major pharmaceutical challenge, due to the inherent instability of these protein-based therapeutics in the harsh environment of the GI tract and their inability to freely permeate across the gut – tissue barrier.
As a result, current IBD biotherapeutics are delivered to patients in hospital via intravenous (IV) infusion or injections. While shown to be effective, these current delivery methods are invasive, time-consuming, and inconvenient for patients. More importantly, they lead to undesired adverse effects, such as immunosuppression, with long-term treatment increasing the chances of developing cancers.
Led by Intract Pharma, we collaborated with SGS Quay Pharma and Pharmidex, forming a consortium to develop the first oral formulation of infliximab. The challenge was to develop a capsule prototype, assess and optimise the processing parameters for large-scale manufacture of the product in preparation for a first-in-human clinical trial.
Intract Pharma’s innovative oral delivery technology has the potential to transform IBD treatment by offering safer and more effective oral biologic therapeutics that patients can easily take at home. Intract’s oral delivery platform comprises its Phloral™ coating on the outside of the capsule, which prevents the premature release of infliximab into the stomach and small intestine, ensuring precise delivery to the colon – the major site of inflammation in IBD.
Once in the colon, another element of the oral delivery platform – the Soteria™ technology – can protect the mAb from enzymatic degradation to ensure high drug levels and maximise tissue uptake.
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-23.png?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1652881231&s=b346cc1bdd0571ba4d8bd8b5eb4801e8 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-23.png?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1652881231&s=458a23b6207e70201321bad8d0d62faf 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-23.png?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1652881231&s=f9b0547ce3a66efa1f8248861de96d80 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-23.png?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1652881231&s=ce9c9d51985cd838feb865103f836839 960w)
“Thanks to the expertise in drug development and manufacture brought by the colleagues from Quay, CPI and Pharmidex, we successfully developed a scalable manufacturing process for oral antibody products.”
![Silvia Matiz Silvia Matiz](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/silvia-matiz.jpeg?w=100&h=100&q=60&fm=jpg&fit=crop&dm=1657640876&s=3014c08ddd68c8c7cdc8a1fd6e55147a)
How CPI helped
- Definition of quality target product profile
- Capsule core formulation definition and optimisation
- Small-scale development and optimisation of manufacturing process in preparation for scale-up
- Qualitative and quantitative analytical method development
- Stability testing on final product
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1652881249&s=8d40c1c2d1916251741794509bcf83a5 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1652881249&s=be74dd889f1d85ce198bdab24096fd72 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1652881249&s=251c13e741d7d6a04087ae6160821db8 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1652881249&s=d00f3faa0e97e6a89da5cb577e593933 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1652881249&s=b28a9b34d88f4a9b177ebb8da4b0910c 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1652881249&s=479d0a9f40d257c8157dc1120c0242f7 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-20.png?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1652881249&s=d125f941cf025ce975b164d58ff3c6cc 960w)
Achievements
- Determined processing parameters for successful large-scale manufacture of oral infliximab capsule product
- Characterised infliximab in the final drug product
- Assessed stability of infliximab in final drug product under ICH accelerated conditions and determined shelf life of the product
- Gave Intract Pharma the proof-of-concept to take the oral infliximab product to clinical trials
Impact
Oral biologics, such as the infliximab capsule, have the potential to be life-changing for the half-a-million sufferers of Crohn’s and colitis in the UK. If this product becomes available, it could transform patient care by offering a less invasive and painless therapy, with a better safety profile compared to the respective injectable products currently on the market. Medications could be taken at home, without the need for hospital visits, leading to a cheaper and simpler treatment process that would also be beneficial to patients’ adherence to therapy.
Oral infliximab could also have an impact on hospital resourcing. By removing the need for IBD patients to go into the hospital for IV infusions, trained personnel and medical staff could be allocated to other areas. This would save on staff resources and ultimately costs, which is extremely valuable for hospitals recovering from the recent pandemic.
We’ve helped to propel this revolutionary treatment to clinical trials, making it one step closer to a viable reality for Intract Pharma and people living with IBD.
Partners
![Intract Pharma](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/Intract-Pharma-logo.png?w=240&h=102&q=75&fm=png&fit=crop&dm=1652371682&s=e3c15e1ca8a270b0f5f59f8576f1449f)
![Pharmidex](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/Pharmidex-V2-Stacked-02.jpg?w=400&h=554&q=100&fm=png&fit=crop&dm=1652371701&s=ef57e8a67542b7e1064a78c850fdceba)
![Quay Pharma](https://optimise2.assets-servd.host/smart-hoopoe/production/content/logos/quay-pharma-logo.png?w=400&h=266&q=100&fm=png&fit=crop&dm=1652884483&s=2142a27f390c66ce79d180203b2a0494)
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