Phage Product Candidate for Pseudomonas aeruginosa Respiratory Infections
Developed by Armata, AP-PA02 is a phage candidate that targets the pathogen Pseudomonas aeruginosa, to treat serious respiratory infections, with an emphasis on cystic fibrosis (CF) patients.
AP-PA02 is being developed as a replacement for AP-PA01 (previously known as AB-PA01), which was recently featured in the peer-reviewed journal Infection following the successful treatment of a multidrug-resistant P. aeruginosa infection in a CF patient (Press Release). Armata leveraged its experience with AP-PA01 to develop the new therapeutic candidate AP-PA02, which is comprised of a mixture of complementary phages (synthetic and natural) that we believe offer improved host range, increased potency (more robust killing kinetics) and aid in preventing the development of resistance.
To identify AP-PA02, Armata screened a large diverse panel of P. aeruginosa isolates from CF patients in the US and Europe against its proprietary phage library. AP-PA02 demonstrated broad coverage against approximately 90% of tested clinical isolates. Manufacturing of clinical trial material is underway at Armata’s production facility in Marina del Rey, CA, using cGMP, to support filing of an IND Application with the US FDA. In addition, Armata intends to file a clinical trial application with the relevant competent authority in Europe to initiate a clinical trial evaluating the safety and tolerability of AP-PA02 in CF patients chronically infected with P. aeruginosa.
P. aeruginosa is consistently recognized as among the most dangerous respiratory pathogens associated with significant impacts on health, quality of life, and economic burden. The problem is further complicated by rising rates of antibiotic resistance. Pseudomonas is particularly problematic for CF patients given that their compromised lung function leads to chronic infections. There are approximately 70,000 CF patients worldwide, of which up to 85% develop chronic P. aeruginosa infection by age 18-25. Median survival age is 40 years. Regular standard of care antibiotics, such as inhaled tobramycin, fail to completely eradicate the pathogen, with a growing number of multidrug-resistant isolates emerging, particularly with long term use.
In addition to CF lung infections, Armata has begun charting the appropriate clinical and regulatory paths for other respiratory infections with high unmet medical need, including hospitalized pneumonia (hospital-acquired pneumonia: HAP; ventilated-associated pneumonia: VAP). HAP/VAP is the most common cause of death among all hospital‐acquired infections, with mortality rates ranging as high as 35‐50% driving considerable healthcare costs, and accounting for around 50% of all intensive care unit antibiotics.
In addition to our Pseudomonas phage program, Armata’s development of a synthetic phage targeting S. aureus would increase the number of treatable patients with, and market for the treatment of, respiratory infections including CF lung infections and hospitaized pneumonia.