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The U.S. Food and Drug Administration (FDA) cleared Armata Pharmaceuticals‘ investigational new drug (IND) application for a Phase 1b/2a clinical trial of AP-PA02 for the treatment of the Pseudomonas aeruginosa bacterial infections that are a hallmark of cystic fibrosis (CF). “We are very pleased that the FDA has cleared our IND, and we plan to initiate clinical development of AP-PA02 by the end of this year,” Todd R. Patrick, Armata’s CEO, said in a press release. P. aeruginosa can colonize the lungs, causing difficult-to-treat infections, which can severely impact both the quality of life and survival rates among people with CF. Treatment for P. aeruginosa infections typically consists of antibiotics. AP-PAo2, conversely, utilizes a cocktail of viruses called bacteriophages to attack the infecting bacteria. Because phages are specific to bacteria — they cannot infect the cells of the patients’ organs — they cause fewer side effects than antibiotics and can target even antibiotic-resistant microbes. AP-PA02 delivers phages specific to P. aeruginosa directly to the lungs via inhalation.
The new trial — called SWARM-P.a. — is a multi-center, double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose trial that will assess the safety and tolerability of AP-PA02 in CF patients with chronic pulmonary P. aeruginosa infections. Armata expects to begin testing in the SAD group later this year. Of note, in a double-blind study, neither the participants nor the researchers know who is receiving the investigational therapy and who is given a placebo. “Results from this study, which we are calling SWARM-P.a. to reflect the manner in which phage attack dangerous pathogens, will be our company’s first clinical trial to evaluate a phage-based therapy as a potential treatment for Pseudomonas aeruginosa airway infections,” Patrick said. “This clinical trial will contribute to the evaluation of the potential of phage to combat multi-drug resistant infections, and potentially usher in a new era in the fight to develop alternatives to antibiotics,” he added. The Cystic Fibrosis Foundation is supporting Armata’s research through a $5 million grant, awarded earlier this year..
