Armata reports data from Phase 1b/2a diSArm trial

Armata Pharmaceuticals (ARMP) announced positive topline results from its Phase 1b/2a diSArm trial which evaluated AP-SA02, a novel intravenous, or IV, administered multi-phage therapeutic for the treatment of Staphylococcus aureus bacteremia, or SAB, in the intent-to-treat, or ITT, population. The diSArm study was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy, or BAT, compared to BAT alone (placebo) for the treatment of adults with complicated SAB. Safety and efficacy were assessed in the ITT population, which included all subjects who received at least one dose of AP-SA02 or placebo. The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at Test of Cure for AP-SA02, defined as one week following the end of IV treatment with AP-SA02, TOC for BAT, defined as one week following the end of IV BAT, and end of study, defined as four weeks following the end of IV BAT. A statistically significant increase in investigator-assessed responder rate was observed at TOC for AP-SA02 in AP-SA02 treated subjects versus placebo. At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent phase 3 trials. Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive S. aureus or methicillin-resistant S. aureua. All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above.