Aridis Pharmaceuticals has begun enrolling patients in what it says will be a pivotal clinical trial of its antibiotic-resistant pneumonia therapy Aerucin.
The trial will cover Aerucin’s ability to combine with standard antibiotics to combat Pseudomonas aeruginosa bacteria. The human monoclonal antibody is designed to bolster the immune system’s response to a range of P. aeruginosa strains, including drug-resistant ones.
Aerucin binds to a polysaccharide — or carbohydrate — called alginate that can be found on the surface of many P. aeruginosa cells. Aridis has done a number of studies showing that Aerucin can both prevent and treat many P. aeruginosa infections.
A pivotal clinical trial is one intended to provide evidence for a drug marketing approval. Aridis’ announcement of the trial did not mention what phase the trial is, but pivotal trials are typically Phase 3.
In preclinical-trial studies, Aerucin prevented mice from dying of P. aeruginosa. It also protected them from eye and sepsis infections.
Patients in 14 countries will take part in the new randomized, double-blind, placebo-controlled trial.
“We are excited to advance the development of Aerucin into a pivotal clinical trial,” Dr. Vu Truong, founder and chief executive officer of Aridis, said in a press release. “This study evaluates the potential therapeutic benefits of our anti-P. aeruginosa antibody Aerucin as an adjunctive therapy in combination with antibiotics in critically ill pneumonia patients.
“Propelled by positive safety data in humans and preclinical evidence that Aerucin is effective against a broad range of P. aeruginosa clinical isolates – including antibiotic-resistant strains – we look forward to evaluating its ability to improve clinical outcomes, compared to standard of care antibiotics alone, in a diverse, global patient population,” he added. “We expect to complete the study in the second half of 2018.”
In January of this year, Aridis received a grant to advance the development of another lung-infection therapy, Panaecin (gallium citrate). The grant came from Cystic Fibrosis Foundation Therapeutics, the drug discovery and development affiliate of the Cystic Fibrosis Foundation.
Panaecin is an aerosol therapy for bacterial infections. Aridia developed it to treat P. aeruginosa, but discovered that it was also effective against other bacterial lung infections, such as Staphylococcus aureus, methicillin-resistant S. aureus, and Burkholderia cepacia.