Aerucin is enrolling patients in 14 countries to determine immunotherapy’s ability to target and kill tough strains.

Privately-held biologics developer Aridis Pharmaceuticals announced it’s begun enrolling patients in a pivotal global study of Aerucin®, a monoclonal antibody (mAb)-based therapeutic designed to fight acute pneumonia caused by antibiotic-resistant pseudomonas aeruginosa bacteria. Aridis will be assessing the efficacy its broadly reactive mAb technology via a 14-country randomized, double blind, placebo-controlled trial.

Driven by preclinical evidence and positive safety data in humans that Aerucin is effective against a range of P. aeruginosa strains, including antibiotic-resistant strains. Vu Truong, Ph.D., Founder and CEO of Aridis said, "We are excited to advance the development of Aerucin into a pivotal clinical trial. This study evaluates the potential therapeutic benefits of our anti-P. aeruginosa antibody … as an adjunctive therapy in combination with antibiotics in critically ill pneumonia patients.” Truong said he expects Aridis will complete the study by the second half of 2018.

Aerucin is based on the company’s proprietary mAb discovery MabIgX® which it uses to produce novel therapies to fight infectious disease including P. aeruginosa. Functionally, Aerucin’s fully human monoclonal lgG1 antibody binds to polysaccharides known as alginates that are well distributed on the surface of the bacteria.

Aridis said that through enhanced complement deposition Aerucin helps the immune system target and kill the disease by promoting the phagocytic defeat of P. aeruginosa clinical isolates — including mucoid and non-mucoid types — as well as antibiotic-resistant strains in pneumonia and cystic fibrosis patients.

Aridis said in an animal model of acute pneumonia, its mAb therapy protected mice from lethal P. aeruginosa illness at doses as low as 0.004 mg/kg. “It also protected animals against eye infections in a keratitis model and sepsis in a systemic infection model,” said Aridis. “These studies support both therapeutic and prophylactic uses of Aerucin against a broad range of P. aeruginosa infections.