Armata Pharmaceuticals announced the Company has developed a new synthetic phage candidate targeting the pathogen Pseudomonas aeruginosa (also referred to herein as "Pseudomonas" or "P. aeruginosa") to treat serious respiratory infections, with an emphasis on cystic fibrosis patients. The candidate, known as AP-PA02, is being developed as a replacement for AP-PA01, which was recently featured in the peer-reviewed journal Infection following the successful treatment of a multidrug-resistant Pseudomonas aeruginosa infection in a cystic fibrosis patient. AP-PA02 is comprised of a mixture of complementary bacteriophages that provide improved host range, increased potency and aid in preventing the development of resistance.
"Pseudomonas 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 cystic fibrosis patients given that their compromised lung function leads to chronic infections," said Todd R. Patrick, Chief Executive Officer of Armata. "The successful case study recently published in Infection demonstrates the potential of our proprietary phage-based therapeutic candidates to combat these very difficult-to-treat respiratory infections, and we have leveraged our experience with AP-PA01 to develop a new, multi-phage synthetic and 'natural' phage therapeutic candidate, AP-PA02, that we believe will provide more robust killing kinetics. Encouraging results from recent nonclinical work has convinced us to elevate the priority of this product to the lead clinical candidate in our pipeline."
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To identify AP-PA02, Armata screened a diverse panel of hundreds of Pseudomonas isolates from cystic fibrosis patients in the United States and Europe against its proprietary phage library. AP-PA02 demonstrated broad coverage against approximately 90% of tested Pseudomonas isolates, providing strong rationale for expedited development. Manufacturing of clinical trial material is underway at Armata's production facility in Marina del Rey, California using current Good Manufacturing Practices, to support filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019. In addition, Armata intends to file a clinical trial application with the relevant competent authority in Europe to initiate a clinical trial evaluating safety and tolerability of AP-PA02 in cystic fibrosis patients chronically infected with P. aeruginosa.
"The fact that we have a Pseudomonas product candidate with potential in the United States and Europe is very exciting," Patrick said. "We will expand testing of isolates from around the world, but for now, we are very satisfied with this product candidate to address a majority of medical need in two very important geographical regions and are committed to meeting regulatory and clinical milestones in the coming months."