Armata Pharmaceuticals Announces Positive Topline Data from Phase 1b/2a SWARM-P.a. Clinical Trial of Inhaled AP-PA02 in Patients with Cystic Fibrosis
- Category: DNA RNA and Cells
- Published on Monday, 06 March 2023 15:20
- Hits: 1989
AP-PA02 is well-tolerated and data supports progression to Phase 2b
Also announces first subject dosed in Phase 2 'Tailwind' clinical trial of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB)
NCFB represents Armata's third active clinical program
MARINA DEL REY, CA, USA I March 6, 2023 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 positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients.
"We are pleased to present topline data for our lead multi-phage candidate, AP-PA02, which was evaluated in cystic fibrosis patients in the SWARM-P.a. clinical trial, and to announce the dosing of the first subject in our Tailwind study of AP-PA02 in NCFB," stated Mina Pastagia, MD, MS, Chief Medical Officer at Armata. "The data from our SWARM-P.a. study gives us confidence that the pharmacokinetics of inhaled phage are predictable and suggest that optimized exposures will correlate with bacterial load reduction. CF and NCFB are chronic pulmonary disorders in which the bronchi become permanently dilated due to a cycle of mucus production, inflammation, and lung tissue damage. The airways often then become colonized by Pseudomonas aeruginosa, with the same bacterial lineage persisting in the lungs of patients for decades despite the use of life-long inhaled antibiotics."
The SWARM-P.a. trial was a multi-center, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study that evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AP-PA02.
Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event (TEAE) profile similar to placebo. Only mild, self-limited adverse events possibly related to study drug were reported in a few subjects.
PK findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure. Single ascending doses (SAD) and multiple ascending doses (MAD) resulted in a proportional increase in exposure as measured in induced sputum. Additionally, achieved exposures were relatively consistent from subject to subject.
Bacterial levels of P. aeruginosa in the sputum were measured at several timepoints and compared to baseline levels prior to study drug administration. Trends suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at end of treatment as compared to placebo after ten days of dosing. Importantly, for subjects with the highest average exposure of susceptible phage, there was durability of approximately two-log reduction from end of treatment to end of study (day 28 post dose). PK/PD analysis indicates significant microbiological impacts in the subjects with highest exposures.
Armata also announced today that it has dosed the first subject in its Tailwind study of nebulized AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB). The Tailwind study (NCT05616221) is a double blind, randomized, placebo-controlled trial that will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 as monotherapy, as well as in combination with inhaled antibiotics. Pharmacokinetic data from SWARM-P.a. were used to design an optimized AP-PA02 dosing regimen for the Tailwind study. Insights from Tailwind will be important for the concurrent design of the Phase 2b cystic fibrosis study, which will be powered to evaluate the efficacy and durability of phage response over time.
"Data from Tailwind, together with our recently completed SWARM-P.a. trial, are intended to provide further evidence of the clinical value of phage therapy as a novel approach for the treatment of chronic, biofilm-related respiratory infections, and will hopefully move Armata one step closer to establishing phage as a new and powerful class of anti-infectives," stated Dr. Pastagia.
"The initiation of patient dosing in the Tailwind study represents our third active clinical program, highlighting our commitment to bring much needed innovation to clinical indications where antibiotic therapy is failing," stated Dr. Brian Varnum, Chief Executive Officer of Armata. "In addition to our recently completed SWARM-P.a. study, we have line-of-sight to two additional data readouts that can potentially provide new hope to patients suffering from serious and difficult to treat bacterial infections."
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific 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. 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