Revolutionary new oral medicine to treat inflammatory bowel disease developed by industry collaboration
19 May 2022
An innovative capsule could take the gold-standard treatment for Crohn’s disease and ulcerative colitis out of hospital and into patients’ homes for the first time.
We worked with Intract Pharma, SGS Quay Pharma, and Pharmidex to successfully repackage the biologic drug infliximab into a safer, more effective and more convenient oral capsule.
Never before has an oral monoclonal antibody treatment been clinically viable and commercially available. Now ready for human clinical trials, this new oral drug product could change that, along with the lives of millions of people living with Crohn’s disease and ulcerative colitis – the two main types of inflammatory bowel disease (IBD).
For most people with Crohn’s and colitis, the monoclonal antibody therapy infliximab is the first-choice biologic treatment to control the disease. But receiving this gold-standard therapy can be painful, time-consuming, and cause adverse effects such as immunosuppression.
Infliximab is usually administered by intravenous infusion – requiring 2 hours in hospital each time, alongside routine patient monitoring. Developing an oral delivery method is challenging. Drugs must survive the digestive system’s harsh environment and reach the colon intact to be most effective.
Formulating infliximab as an oral capsule is transformational. If human clinical trials are successful and once on the market, patients will be able to simply wake up in the morning and swallow a tablet. The oral version of infliximab is more targeted and has fewer side effects than the injectable product. It is also cheaper to produce and deliver, thereby reducing demands on healthcare resources.
![Three females in lab coats and goggles talking to each other in one of CPI's labs. Three females in lab coats and goggles talking to each other in one of CPI's labs.](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)
Silvia Matiz, Formulation Scientist at Intract Pharma, who managed the project, highlighted the impact of this collaboration on the development of orally administered biological medicines:
“Over the past years, Intract has been working really hard in the development of technologies to allow for oral delivery of biologics – the ‘holy grail’ in the pharmaceutical industry. Protein-based therapeutics are generally unstable in the harsh conditions of the gut and rapidly degrade before being able to exert any effect.”
The innovative oral delivery technology packages infliximab in a dual-purpose manner. The Phloral™ coating precisely releases the antibody in the colon, the main site of inflammation in IBD patients. The Soteria® technology prevents the digestive enzymes from prematurely degrading the drug, maximising uptake in the diseased tissue.
The consortium was set the challenge of developing Intract Pharma’s technologies into a capsule prototype containing infliximab. Using in-house bioprocessing expertise and state-of-the-art biologics manufacturing and formulation facilities, CPI helped optimise the oral infliximab product and prepared it for scale-up and manufacture.
![An animated image showing a colon inside the human body with the infliximab capsule inside it. An animated image showing a colon inside the human body with the infliximab capsule inside it.](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-25.png?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1652881218&s=ce60ff1c4602573b683171da3c93d9a2 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-25.png?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1652881218&s=fdfd5d0a0bb419e5e24683cbdf232988 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-25.png?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1652881218&s=b4d8fb9c41cefa6bdb2fc9078d712dbf 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-25.png?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1652881218&s=7739daa7f006347ed8823ce199511f2a 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-25.png?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1652881218&s=fc6fbbb7f72c0fe2621bd75d6c485e44 960w)
John Arthur, Director of Medicines Manufacturing and Biologics at CPI, said:
“Every day at CPI we work together with industry partners to create lasting impact through deep tech innovation. Through our collaboration with Intract Pharma, SGS Quay Pharma and Pharmidex we were able to provide a solid proof-of-concept to take the novel oral infliximab product to clinical trials and bring a transformative treatment one step closer to reality for the millions of people with Crohn’s and colitis around the world.”
The ambitious, collaborative project also included pre-clinical studies conducted by Pharmidex and scale-up by SGS Quay Pharma.
Silvia Matiz added:
“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, taking the oral Infliximab one step closer to the clinic.”
![An animated image showing an oesophagus inside a human head/neck with the infliximab capsule being swallowed. An animated image showing an oesophagus inside a human head/neck with the infliximab capsule being swallowed.](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-26.png?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1652881216&s=260242f8d7d26d313fc768df7be31d14 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-26.png?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1652881216&s=3d0311cd4fa3ff9951014f821df2ee02 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-26.png?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1652881216&s=ad3270ba3c4eca1a9ca99faea30b0b21 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-26.png?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1652881216&s=67e1c29cfb27a050c688de39b1bd5b6c 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MicrosoftTeams-image-26.png?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1652881216&s=befc35d5a8d314df751b14504ec431b8 960w)
Mo Alavijeh, Director at Pharmidex, said:
“IBD is a lifelong, often debilitating condition, with no cure, which affects adults and children of all ages. Over 500,000 people in the UK have IBD, with an estimated cost to the NHS of £720 million.
“We are delighted that the Pharmidex Oncology team, headed by Dr Christopher Ireson, was part of this innovative project working closely with Intract Pharma, SGS Quay Pharma and CPI to enable this project to progress swiftly towards clinical development, ultimately leading to reducing the suffering of IBD patients.”
Mike Frodsham, Chief Technical Director at SGS Quay Pharma, added:
“We are excited to have been part of this early-stage collaborative project. Oral delivery of large molecules poses multiple challenges; this project goes some way to addressing the future potential for targeted delivery using scalable manufacturing processes. We look forward to seeing the outcome of future studies conducted by Intract and hope for a more manageable dosage form for Crohn’s disease patients in the future.”
In 2018, the partnership secured more than £1.4 million in funding through UK Research and Innovation’s Industrial Strategy Challenge Fund for innovative projects in medicines manufacturing and contributions from industry partners. The innovative manufacturing approaches developed during the project could help formulate and stabilise other biologic medicines in the future.
Nicholas Medcalf, Deputy Director of UKRI’s medicines manufacturing challenge, said:
“Two of the key aims of UK Research and Innovation’s medicines manufacturing challenge are to improve commercial viability and to develop methods for scale-up. That’s why, in 2018 we provided more than £1.1 million in funding to this project. I am pleased to see our investment has supported the production of this novel drug delivery method, which will improve the lives of patients, and the innovative processes that could help formulate and stabilise other biologic medicines in the future.”
Let’s innovate together
To find out more about how we can work together, please enter your details below.