SGS’s Quay Pharma Collaborates to Develop New Oral Medicine for Inflammatory Bowel Disease

SGS's Quay Pharma has partnered with Intract Pharma, CPI 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 the lives of millions of people living with Crohn's disease and ulcerative colitis – the two main types of inflammatory bowel disease (IBD) – by taking gold standard treatment out of the hospital and into the home.

For most people with Crohn's and colitis, the monoclonal antibody therapy infliximab is the first choice biologic treatment. But receiving intravenous infusion therapy can be painful and time consuming and cause adverse effects such as immunosuppression.

Formulating infliximab as an oral capsule – which must survive the digestive system's harsh environment and reach the colon intact – is transformational. If human clinical trials are successful, once the drug is on the market patients will be able to simply swallow a capsule when they wake up in the morning. The oral version of infliximab is more targeted, with fewer side effects than the injectable products. It is also cheaper to produce and deliver, reducing demands on healthcare resources.

Infliximab uses innovative oral delivery technology packaged in a dual purpose manner. A Phloral^™ coating precisely releases the antibody in the colon, the main site of inflammation in IBD patients. Soteria^® technology prevents digestive enzymes from prematurely degrading the drug, maximizing uptake in the diseased tissue.

The consortium was set the challenge of developing Intract Pharma's technologies into a capsule prototype containing infliximab. CPI helped optimize the oral infliximab product formulation and SGS's Quay Pharma scaled the process for clinical evaluation. SGS's Quay Pharma provides a comprehensive outsourcing service for formulation and analytical development with subsequent clinical trials and commercial manufacturing for pharmaceutical and biotechnology companies worldwide.

Silvia Matiz, Formulation Scientist at Intract Pharma, who managed the project, highlighted the impact of this collaboration on the development of orally administered biologic medicines: "Over the past years, Intract has been working really hard on the development of technologies to allow for oral delivery of biologics – the 'holy grail' in the pharmaceutical industry. We have successfully developed a scalable manufacturing process for oral antibody products, taking oral infliximab one step closer to the clinic."

John Arthur, Director of Medicines Manufacturing and Biologics at CPI, said, "Through our collaboration, we were able to bring a transformative treatment one step closer to reality for the millions of people with Crohn's and colitis around the world."

Mike Frodsham, Chief Technical Officer for formulation and clinical manufacturing services at SGS's Quay Pharma, said, "Oral delivery of larger molecules poses multiple challenges. This goes some way to addressing the future potential for targeted delivery using scalable manufacturing processes."

Mo Alavijeh, Director at Pharmidex, commented, "IBD is a lifelong, often debilitating condition, with no cure, which affects adults and children of all age. We are delighted that the Pharmidex Oncology team, headed by Dr Christopher Ireson, was part of this innovative project, which will ultimately lead to reducing the suffering of IBD patients."

In 2018, the partnership secured more than £1.4 million in funding through UK Research and Innovation's (UKRI) Industrial Strategy Challenge Fund for innovative projects in medicines, manufacturing and contributions from industry partners.

Nicholas Medcalf, Deputy Director of UKRI's medicines manufacturing challenge, said, "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 stabilize other biologic medicines in the future."

For further information, please contact:

David Humphreys
Health Science
Head of Business Development (Preclinical) and Account Management
t: +44 1244 837 000