Clinical Trial Investigates Cellular Immunotherapy as Treatment for Two Autoimmune Liver Diseases

Orbsen Therapeutics, an NUI Galway spin-out biotechnology company focused on the development and commercialisation of stromal cell immunotherapies, announced its second generation immunotherapy ORBCEL-C is being administered to patients participating in MERLIN, a multi-site UK-based clinical trial to determine the therapy’s safety and effectiveness in treating two types of chronic autoimmune liver diseases.

Dr Larry Couture, CEO of Orbsen Therapeutics, said: “Orbsen’s product pipeline featuring ORBCEL immunotherapies has tremendous potential to make a significant impact on illnesses related to diabetes, autoimmunity, and inflammation, as well as chronic liver diseases.” 

MERLIN is investigating ORBCEL-C’s ability to safely and effectively treat individuals with primary sclerosing cholangitis (PSC), a condition characterised by inflammation in the bile ducts, and autoimmune hepatitis (AIH), a disease which causes the body’s immune system to attack the liver. If left untreated, both conditions may lead to cirrhosis or liver failure and subsequently require liver transplantation.

Dr Stephen Elliman, Chief Scientific Officer at Orbsen Therapeutics and who discovered the ORBCEL therapy at NUI Galway, said: “Patients suffering with PSC and AIH have few therapeutic options today, and most patients require liver transplantation. We are optimistic taking ORBCEL-C immunotherapy to the clinic as a solution to preserve liver function and slow progression of these autoimmune liver diseases, ultimately reducing the need for liver transplants in these patients.”

The clinical trial, which will follow as many as 56 patients through the treatment process, is under the direction of Chief Investigator Professor Phil Newsome from the University of Birmingham’s Institute of Immunology and Immunotherapy. Study sites include Birmingham, Oxford, and Nottingham.

“I am very excited about the potential benefits of this treatment for patients with PSC and AIH,” said Professor Newsome. “There is good evidence the selected cells within this new immunotherapy can reduce liver inflammation and improve liver function. The study aims to prove the treatment’s safety and efficacy, and explore the possibility it may be applied to future clinical trials to address other immune and inflammatory diseases.”

Orbsen’s proprietary ORBCEL technology yields nearly 100 percent pure stromal cells, a significant increase in purity when compared to first generation stromal cell therapies.

Orbsen is currently enrolling and treating patients in three additional clinical trials to assess ORBCEL’s safety and efficacy in the prevention and treatment of diabetic kidney disease, non-healing diabetic foot ulcers and moderate to severe acute respiratory distress syndrome (ARDS). Another trial is pending for patients with several auto-immune disorders.