Omni Bio Pharmaceutical, Inc. announced the first disclosure of important results for its recombinant molecule, Fc-AAT. Leo A. B. Joosten, PhD, of the Radboud University Medical Center, Nijmegen, The Netherlands, presented data on therapeutic applications of Fc-AAT in gout at the 4th European Workshop on Crystals in Human Diseases in Paris, France. Dr. Joosten reported on several studies that he and colleagues performed in mouse models of gouty athritis showing that Fc-AAT: effectively suppressed pro-inflammatory responses as measured by cell influx, joint swelling, IL-1 and IL-6 levels in a dose-dependent manner; exhibited a significant reduction (85%) in these parameters at a relatively low dose of 50 ug (2 mg/kg per mouse) that was at least as effective as a high dose (10 mg/mouse) of the IL1 receptor antagonist anakinra; was at least 40 times more potent than a clinical grade of plasma-derived AAT; exhibited a prolonged duration of action relative to plasma-derived AAT.

The study also concluded that Fc-AAT has a unique mechanism of anti-inflammatory action that occurs through modulation of TLR2 and TLR4 expression, suppression of a variety of pro-inflammatory cytokine mediators, inhibition of capsase-1 activation and induction of IL1 receptor antagonism. AAT is the most abundant circulating serine protease inhibitor in the body and an acute phase reactant. Systemic deficiency in AAT due to genetic mutations can result in debilitating liver failure and chronic lung disease such as emphysema.

Lifelong treatment with plasma-derived AAT, intravenously administered, is indicated for such patients. Recent evidence suggests that AAT plays an important role in modulating immunity, inflammation and apoptosis. AAT protects various cell types from cell death, inhibits caspases-1 and -3 activity and has been shown to be effective in a wide variety of animal models of human disease, including diabetes, graft versus host disease (rejection reactions following bone marrow or other transplantation procedures), gout, myocardial infarction and inflammatory bowel disease.