Armata Pharmaceuticals announced that data from the Phase 1b/2a SWARM-P.a. SAD/MAD study of its AP-PA02 nebulized phage therapy in cystic fibrosis patients with chronic P. aeruginosa lung infections “confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure.” The company had announced the completion of the SWARM-P.a. study in December 2022. Armata also said that it has initiated a recently announced Phase 2 study of AP-PA02 for non-cystic fibrosis bronchietasis.
According to Armata, the SWARM-P.a. study found that inhaled AP-PA02 was well tolerated, with exposures that were proportional to the dose and “relatively consistent” between subjects. The company said that after 10 days of treatment, “Trends suggest improvement in bacterial load reduction for subjects treated with AP-PA02” compared to those who received a placebo and that “PK/PD analysis indicates significant microbiological impacts in the subjects with highest exposures.”
The company said that it used PK data from the CF study in the design of the Tailwind study, which will evaluate the efficacy of AP-PA02 versus placebo in NCFB patients and that, “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.”
Armata Chief Medical Officer Mina Pastagia said, “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. 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.”
CEO Brian Varnum commented, “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. 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.”
Read the Armata Pharmaceuticals press release.
