Armata Pharmaceuticals Announces Clearance of Investigational New Drug (IND) Application to Initiate Phase 1b/2a Clinical Trial of Lead Candidate AP-PA02 in Pseudomonas aeruginosa Infections
- Category: DNA RNA and Cells
- Published on Friday, 16 October 2020 14:13
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Upcoming study, to be known as "SWARM-P.a.," is believed to be first FDA cleared, controlled clinical trial to evaluate a multiple phage-based mixture as a therapeutic candidate in Cystic Fibrosis patients
MARINA DEL REY, CA, USA I October 15, 2020 I Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on precisely targeted 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 IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections.
"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, consistent with our original guidance notwithstanding disruptions to drug development timelines across the industry caused by the COVID-19 pandemic," stated Todd R. Patrick, Chief Executive Officer of Armata Pharmaceuticals. "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. 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."
"Pseudomonas aeruginosa infections are particularly dangerous for cystic fibrosis patients, and I would once again like to express my gratitude to the CF Foundation for the important financial and clinical support that they are providing to help advance this candidate through clinical trials as efficiently as possible. While the study will initially evaluate AP-PA02 in combination with standard antibiotics, our ultimate goal with this product candidate is to replace antibiotics as a front-line therapy," Mr. Patrick concluded.
The SWARM-P.a. study will be a Phase 1b/2a, multi-center, double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa infection. Barring worsening COVID-19 conditions, Armata expects to initiate the SAD cohort by the end of this year.
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