Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today the initiation of a Phase 1 clinical study of Aerucin™, the Company's fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, which is being developed as an adjunctive treatment for acute pneumonia. Aerucin has also filed for Orphan Disease Designation with the U.S. Food and Drug Administration in the United States and in Europe.
The clinical trial, expected to complete in the third quarter of 2015, is a Phase 1 single ascending dose study in healthy volunteers. Advancing to this stage of development represents the culmination of longstanding collaborations with Harvard University and the National Institutes of Health.
Founder and Chief Executive Officer, Vu Truong, Ph.D., stated, "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."
Aerucin directly binds the alginate polysaccharide on the cell surface of P. aeruginosa. It was discovered using Aridis' proprietary MabIgX® technology by screening human B-cells for antibodies that demonstrated improved immune recognition and phagocytic destruction of more than 90% of all Pseudomonas aeruginosa. Earlier preclinical studies of Aerucin support both therapeutic and prophylactic use of the monoclonal antibody.