Company: ARMP
Filing Date: 2025-12-01
Form Type: 424B5
Source: 0001104659-25-117382
Chunk: 40

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-12-01
Form: 424B5
Chunk 40
---
 with complicated
SAB. All doses of AP-SA02 were dosed intravenously every six hours for five days. 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 (i) Test
of Cure (TOC) for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined
as one week following the end of IV BAT, and (iii) end of study (EOS), defined as four weeks following the end of IV BAT. Clinical
outcome was evaluated by both the blinded investigators and a blinded Clinical Efficacy Adjudication Committee (CEAC) in the intent-to-treat
(ITT) population.

Safety
and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo.
AP-SA02 was well-tolerated with no serious adverse events related to the study drug. Two subjects had adverse events that were possibly
related to the study drug: one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation
of vancomycin.

A statistically significant
increase in investigator-assessed responder rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%) versus placebo
(58%) (p = 0.047). At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) 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 (MSSA) or methicillin-resistant S. aureus (MRSA). 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. Supporting the investigator assessment, clinical outcome was assessed by the CEAC, who
agreed that subjects who received placebo had a 22% and 25% non-responder rate at TO