Jan. 5, 2022
The improvements in AP-PA02 reflect Armata’s core strategy of utilizing clinical isolate surveillance data to drive enhancement of product composition. Prior to initiating the SWARM-P.a. trial, Armata’s clinical isolate screening and phage collections yielded a three-phage cocktail with compelling host-range coverage. Since then, Armata’s ongoing discovery efforts have resulted in a P. aeruginosa phage library that encompasses more than 600 unique phages and a P. aeruginosa isolate collection that represents contemporary and historical clinical isolates with geographic diversity from relevant respiratory sources (CF, NCFB, and pneumonia). This library of more than 2,000 clinical isolates (~1,000 genomes sequenced) has powered Armata’s ability to strengthen the profile of AP-PA02. The optimized phage cocktail introduces two new phage genera, which provides coverage of at least 90% of tested P. aeruginosa clinical isolates and has shown superior in vitro potency as well as improved efficacy in an animal model of infection. Utilizing Armata’s in-house capabilities, the two new phages were rapidly advanced through manufacturing and regulatory review and are now entering the ongoing SWARM-P.a. study.
Screening P. aeruginosa isolates from people diagnosed with NCFB revealed that the five-phage AP-PA02 cocktail offers broad coverage and robust potency in this indication as well. NCFB is a serious respiratory disease characterized by chronic inflammation of airways, decline of lung function, and frequent lung infections with P. aeruginosa. There are currently no approved inhaled antibiotics for the treatment of NCFB patients with chronic P. aeruginosa respiratory infections. Recognizing this high unmet medical need, Armata plans to advance quickly into a Phase 2 trial in NCFB in 2022.
Conversely and representing the different physiology of acute pneumonia lung infections as compared to chronic CF and NCFB respiratory infections, a novel cocktail is in development for the clinical indication of pneumonia. Armata has deployed its extensive clinical isolate collection and phage library to identify a candidate 5-phage cocktail (AP-PA03) that is entering manufacturing with a regulatory filing expected in 2022.
“As we enter 2022, we are realizing the benefits of our commitment to the core science of bacteriophage therapy,” stated Dr. Brian Varnum, Chief Executive Officer of Armata Pharmaceuticals. “Armata’s strategy is to deliver high quality defined phage products that cover the vast majority of clinical isolates in an indication. We also realize the value of ongoing surveillance that may, from time to time, justify introducing new phage to refine or improve a product. Our ability to introduce two new phages during clinical development is an important step in the execution of this strategy. Further, we believe AP-PA02 represents a best-in-class product for CF.”
“We are very pleased to incorporate the enhanced AP-PA02 into the SWARM-P.a. study. This allows us to generate safety and efficacy data for AP-PA02 in 2022 and positions us to rapidly advance an optimized product into registrational trials,” stated Dr. Mina Pastagia, Armata’s Senior Vice President of Clinical Development. “Additionally, following IND approval for our ‘diSArm’ study, which is assessing AP-SA02 in Staphylococcus aureus bacteremia, we are focusing on startup activities and further expanding our clinical pipeline with the pursuit of new indications such as NCFB and pneumonia.”