Study Expected to Complete in 4Q 2015
SAN JOSE, CA, USA I March 26, 2015 I Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel immunotherapies for infectious diseases, announced today the initiation of a Phase 1 clinical study of Aerucin™, the Company’s broadly reactive, fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, which is being developed as an adjunctive treatment for acute pneumonia.
The Phase 1 clinical trial, expected to complete in the fourth quarter of 2015, is a single ascending dose safety and pharmacokinetics study in healthy volunteers. Advancing to this stage of development represents the culmination of longstanding collaborations with Harvard University and the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH). An Investigational New Drug (IND) application was recently filed with the U.S. Food and Drug Administration (FDA), which was approved in a timely fashion by the Agency.
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 polysaccharide alginate, widely expressed on the cell surface of P. aeruginosa, leading to complement deposition and improved immune recognition. Aerucin demonstrated phagocytic destruction of more than 90% of all Pseudomonas aeruginosa clinical isolates tested. Earlier preclinical studies of Aerucin support both therapeutic and prophylactic use of the monoclonal antibody.
About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® and pharmaceutical formulation technologies to produce novel infectious disease focused therapies. Aridis’ product pipeline includes AR-101 anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin™, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia and cystic fibrosis; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. Complementing the company’s portfolio of mAbs is Panaecin™, a novel broad spectrum anti-infective with activities against bacteria, viruses, and fungi.
SOURCE: Aridis Pharmaceuticals
Post Views: 105
Study Expected to Complete in 4Q 2015
SAN JOSE, CA, USA I March 26, 2015 I Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel immunotherapies for infectious diseases, announced today the initiation of a Phase 1 clinical study of Aerucin™, the Company’s broadly reactive, fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, which is being developed as an adjunctive treatment for acute pneumonia.
The Phase 1 clinical trial, expected to complete in the fourth quarter of 2015, is a single ascending dose safety and pharmacokinetics study in healthy volunteers. Advancing to this stage of development represents the culmination of longstanding collaborations with Harvard University and the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH). An Investigational New Drug (IND) application was recently filed with the U.S. Food and Drug Administration (FDA), which was approved in a timely fashion by the Agency.
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 polysaccharide alginate, widely expressed on the cell surface of P. aeruginosa, leading to complement deposition and improved immune recognition. Aerucin demonstrated phagocytic destruction of more than 90% of all Pseudomonas aeruginosa clinical isolates tested. Earlier preclinical studies of Aerucin support both therapeutic and prophylactic use of the monoclonal antibody.
About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® and pharmaceutical formulation technologies to produce novel infectious disease focused therapies. Aridis’ product pipeline includes AR-101 anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin™, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia and cystic fibrosis; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. Complementing the company’s portfolio of mAbs is Panaecin™, a novel broad spectrum anti-infective with activities against bacteria, viruses, and fungi.
SOURCE: Aridis Pharmaceuticals
Post Views: 105
