Armata Pharmaceuticals, Inc. announced that it has achieved full enrollment (n=50) of its Phase 1b/2a diSArm study of intravenous AP-SA02 as a potential treatment for Staphylococcus aureus (S. aureus) bacteremia. Armata anticipates topline data from the diSArm study in the first quarter of 2025. During the Phase 2a portion of diSArm, Armata focused on evaluating clinical safety of higher intravenous doses of AP-SA02 and accelerating enrollment to arrive at topline data expeditiously.

The manufacture of highly purified phages using Armata's proprietary methods enabled dose escalation to 5E10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed. One subset, comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood providing early evidence of in vivo phage amplification and resultant release of phage progeny.

The Company anticipates topline data from the diSArm study in the first quarter of 2025 where it can explore the two aforementioned subsets in an unblinded manner. Topline results are also expected to inform the optimal dose of AP-SA02 to be evaluated in the larger definitive efficacy study. Armata remains committed to developing a pivotal S. aureus bacteremia trial in 2025 to evaluate the intravenous phage product candidate, AP-SA02, as an adjunct to standard of care broad-spectrum antibiotics and/or potentially as an alternative to broad-spectrum antibiotics.

Modern medicine requires a hard look at reliance on broad-spectrum antibiotics and their detrimental impact on the healthy human microbiome. The Company plans to discuss its pivotal trial design with the U.S. Food and Drug Administration. The clinical development of AP-SA02 is supported in part by $21.6 million funds from the Defense Health Agency and Joint Warfighter Medical Research Program received through the MTEC and managed by the NMRC-NAMD.

The diSArm study is a Phase 1b/2a, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy (BAT) compared to BAT alone for the treatment of adults with bacteremia due to S. aureus. The Phase 1b portion evaluated the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with S. aureus bacteremia. The Phase 2a portion evaluated the efficacy, safety, and tolerability of multiple doses of intravenous AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated S. aureus bacteremia.