NovImmune Initiates a Proof-of-Concept Study

PBC is an orphan, autoimmune, progressive liver disorder that primarily affects females. Typically, the disease becomes apparent during middle age (between 30 and 65). Inflammation, developing around the small bile ducts, progressively induces an obstruction and accumulation of bile leading to damage of liver cells. As damage worsens, scarring (cirrhosis) gradually occurs and may ultimately cause liver failure, for which transplantation is the only therapeutic option. Common early symptoms of PBC are itching and fatigue. Currently, only symptomatic treatments are available and the need for disease modifier drugs is extremely high.

NovImmune announced that a Proof-of–Concept (PoC) study with NI-0801, a fully human monoclonal antibody neutralizing the CXCL10/Interferon-gamma-inducible protein-10 (IP-10) chemokine, was initiated in patients with PBC.  Preclinical models and human data strongly associate CXCL10/IP-10 to the etiology of PBC. Two previous Phase I trials in healthy volunteers have demonstrated that the administration of NI-0801 is safe and well tolerated.