Tony Hagen is senior managing editor for The Center for Biosimilars®.
Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.
Celltrion companies have developed biosimilar forms of infliximab for subcutaneous and intravenous use, but now the Incheon, Republic of Korea—based Celltrion Group is developing what would be the world’s first oral infliximab formulation, a tumor necrosis factor–alpha inhibitor, for the treatment of inflammatory bowel disease (IBD).
Celltrion is doing this in collaboration with the United Kingdom—based Intract Pharma, which specializes in oral therapies.
“A technical alliance between Intract Pharma and Celltrion Group allows for the development of oral infliximab that is safe, highly efficacious, and convenient,” Celltrion Group said in a statement.
Intract will be responsible for development and clinical validation of the product. Celltrion will supply drug material and provide support.
Clearance for Trials
Intract said in a statement that the proposed oral infliximab product has UK approval to proceed to phase 1b/2a clinical trials in patients with IBD. Those trials are expected to commence in the second half of 2021, without a requirement for additional preclinical research or a clinical safety study.
Officials said the oral infliximab is expected to be stable at room temperature, “offering simple distribution, storage, and administration for patients at home.”
Based on this partnership, more oral antibodies could be developed, they added. “Collaboration between the two parties is expected to open new doors for the development of additional orally-delivered antibodies.”
“We anticipate that the oral infliximab product which we will co-develop with Celltrion Group will have an improved safety profile and will offer a less expensive biotherapeutic treatment for IBD. We are hopeful that the product will address a large proportion of the IBD market, potentially replacing steroid and immune-suppressive drugs in addition to capturing a large share of the biologics market,” said Bill Lindsay, CEO of Intract.
Celltrion Group includes Celltrion and Celltrion Healthcare. The 2 companies are interconnected and do research, development, and manufacture of biosimilars and other drugs.
Intract Pharma “has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients,” the company said.
Celltrion's infliximab (Rensima) is also being tested in the CATALYST trial as a possible inflammation control for patients with coronavirus disease 2019.