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.

“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, Formulation Scientist – Intract Pharma

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

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.