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Preliminary clinical trial of AR-101 (AerumabTM) anti-P. aeruginosa (Pa) IgM mAb in pneumonia patients provided important proof-of-concept evidence that anti-Pa mAbs can be safe and effective as an adjunctive therapy to antibiotics and additionally imparts the impetus to refine and improve on this therapeutic concept. We are developing the next generation anti-Pa mAb called AerucinTM that is best-in-class in terms of reactivity, engulfment and killing of different Pa strains. Aerucin is a fully human monoclonal IgG1 antibody that binds to alginate, a widely distributed cell surface polysaccharide on Pa, and enhances complement deposition, leading to improved immune recognition and phagocytic destruction of Pa by the immune system. Compared to all other anti-pseudomonas mAbs that we have tested, Aerucin exhibits the broadest recognition to diverse, unrelated P. aeruginosa clinical isolates. There is extensive data demonstrating Aerucin's effectiveness in phagocytic killing of a wide range of both mucoid and non-mucoid clinical isolates of Pa, including current antibiotic resistant strains from pneumonia and cystic fibrosis patients. Aerucin also protects mice from lethal challenges with a variety of Pa strains in an acute pneumonia model, and protects against eye infections in a keratitis model, and sepsis in a systemic infection model. These studies support the therapeutic and prophylactic uses of Aerucin against a broad range of Pa infections.

Aerucin Mechanism of Action:

While AR-101 is being developed to treat patients with an infection of P. aeruginosa serotype O11, AerucinTM has the potential to treat a broader range of P. aeruginosa infections mainly because its epitope, alginate, is expressed more broadly than LPS serotype O11. Aerucin is different from AR-101 in antibody subtype (IgG as compared to IgM), in eptitope (alginate as compared to LPS serotype O11), in pharmacokinetics and plasma half-life (three to four weeks as compared to three to four days) and in mechanism of action.

Aerucin™: Broadly Active Human IgG mAb Against P. aeruginosa

Monoclonal Antibody Molecules

in Green.

PHARMACEUTICALS

Breakthrough Therapies for

Antibiotic Resistant Infections

Aridis