US-based Aridis Pharmaceuticals has started a Phase I clinical trial of Aerucin, the company’s fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, to treat patients with acute pneumonia.
Aerucin, which is being developed as an adjunctive treatment for acute pneumonia, directly binds the polysaccharide alginate, widely expressed on the cell surface of P. aeruginosa, leading to complement deposition and improved immune recognition.
The single ascending dose safety and pharmacokinetics Phase I trial in healthy volunteers is expected to be completed in the fourth quarter of this year.
According to the company, advancing to this stage of development represents the conclusion of its collaborations with Harvard University and the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH).
Recently, the company has also submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) and it approved in a timely fashion by the agency.
Aridis founder and chief executive officer Vu Truong said: "We are pleased to initiate an accelerated clinical development plan to generate proof-of-concept data that further characterize Aerucin’s bactericidal potency.
"We believe that directing the human immune response to fight life-threatening infections such as those associated with Gram-negative P. aeruginosa bacteria represents the future of new anti-infectives, and will be critical to solving the persistent problem of antibiotic resistance."
Earlier preclinical trials of Aerucin support both therapeutic and prophylactic use of the monoclonal antibody and the drug showed phagocytic destruction of more than 90% of all Pseudomonas aeruginosa clinical isolates tested.
The company uses monoclonal antibody discovery technology MabIgX and pharmaceutical formulation technologies to produce new infectious disease focused therapies.
Image: CT of the chest demonstrating right-sided pneumonia (left side of the image). Photo: courtesy of James Heilman, MD.