Fast Forward Pharmaceuticals has started two Phase II clinical trials of FFP104, a potential treatment for patients with primary biliary cirrhosis (PBC) and Crohn’s disease.

The Dutch firm, which has already completed a Phase I trial in healthy volunteers, licensed FFP104 from PanGenetics.

FFP104 is a clinical-stage humanised anti-CD40 monoclonal antibody, which has been designed to treat several autoimmune diseases and inflammatory conditions.

PBC is thought to originate from an autoimmune attack on the intrahepatic bile ducts, resulting in a disturbed bile acid homeostasis that may eventually lead to liver failure.

"PBC is a disease with precious few treatment options, and new therapeutic modalities are desperately needed."

The first patients have been in enrolled in the Phase II PBC trial, which is being conducted in the Netherlands, the UK and Italy. Results are expected later this year.

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Fast Forward is collaborating with the UK-PBC consortium, an Medical Research Council (MRC) sponsored research network consisting of 150 NHS Trusts across the UK. It aims to discover and develop new and improved treatment modalities for PBC.

Fast Forward Pharmaceuticals CEO Mark de Boer said: "We believe that with its unique mechanism of action, FFP104 holds significant potential as a truly disease-modifying agent in chronic inflammatory conditions and autoimmune diseases.

"PBC is a disease with precious few treatment options, and new therapeutic modalities are desperately needed. Although current medications can help control Crohn’s disease, no cure exists.

"FFP104 is expected to interfere with the abnormal immune reaction underlying the disease, induce long-term remission, lower the risk for developing complications, and the requirement for surgery."

Crohn’s disease is an autoimmune disease that may affect any part of the digestive tract. It can be both painful and debilitating, and may lead to life-threatening complications.

The Phase II Crohn’s disease trial is to be conducted in Belgium and the Netherlands. It builds on the successful results of an earlier trial, conducted by PanGenetics, in which a chimeric version of FFP104 reduced clinical symptoms and improved histological activity scores.