Upon initiation in 2022, the trial will represent the company’s third clinical program in a distinct indication
MARINA DEL REY, CA, USA I February 22, 2022 I Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared Armata’s Investigational New Drug (IND) application to initiate a clinical trial of its optimized lead therapeutic candidate, AP-PA02, in a second indication, non-cystic fibrosis bronchiectasis (“NCFB”). The company plans to initiate a Phase 2 trial in 2022.
In patients with NCFB, lung infection with Pseudomonas aeruginosa is often associated with frequent pulmonary exacerbations, reduced quality of life, and increased mortality, and may require hospital admission for treatment. Although chronic inhaled antibiotics are recommended for long-term management of NCFB with frequent exacerbations, there is currently no approved therapy.
“We are excited to gain FDA clearance to advance AP-PA02 into second respiratory indication,” said Brian Varnum, Chief Executive Officer of Armata. “With this regulatory approval and our recent financing, we are well positioned to explore the clinical benefit of AP-PA02, and to advance AP-SA02 for prosthetic joint infections and AP-PA03 for pneumonia.”
In addition to the upcoming trial of AP-PA02 in NCFB, Armata is also conducting a Phase 1b/2a trial (‘SWARM-P.a.‘) of AP-PA02 targeting Pseudomonas aeruginosa infections in cystic fibrosis patients, and a Phase 1b/2a trial (‘diSArm’) of AP-SA02 targeting Staphylococcus aureus bacteremia.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
SOURCE: Armata Pharmaceuticals
Post Views: 42
Upon initiation in 2022, the trial will represent the company’s third clinical program in a distinct indication
MARINA DEL REY, CA, USA I February 22, 2022 I Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared Armata’s Investigational New Drug (IND) application to initiate a clinical trial of its optimized lead therapeutic candidate, AP-PA02, in a second indication, non-cystic fibrosis bronchiectasis (“NCFB”). The company plans to initiate a Phase 2 trial in 2022.
In patients with NCFB, lung infection with Pseudomonas aeruginosa is often associated with frequent pulmonary exacerbations, reduced quality of life, and increased mortality, and may require hospital admission for treatment. Although chronic inhaled antibiotics are recommended for long-term management of NCFB with frequent exacerbations, there is currently no approved therapy.
“We are excited to gain FDA clearance to advance AP-PA02 into second respiratory indication,” said Brian Varnum, Chief Executive Officer of Armata. “With this regulatory approval and our recent financing, we are well positioned to explore the clinical benefit of AP-PA02, and to advance AP-SA02 for prosthetic joint infections and AP-PA03 for pneumonia.”
In addition to the upcoming trial of AP-PA02 in NCFB, Armata is also conducting a Phase 1b/2a trial (‘SWARM-P.a.‘) of AP-PA02 targeting Pseudomonas aeruginosa infections in cystic fibrosis patients, and a Phase 1b/2a trial (‘diSArm’) of AP-SA02 targeting Staphylococcus aureus bacteremia.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
SOURCE: Armata Pharmaceuticals
Post Views: 42
