Company: ARMP
Filing Date: 2025-08-13
Form Type: S-3
Source: 0001104659-25-077648
Chunk: 11

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: S-3
Chunk 11
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 placebo-controlled dose escalation study to assess the safety, tolerability and
efficacy of our phage-based candidate, AP-SA02, for the treatment of adults with S. aureus(the
“diSArm” study) and to support activities required for an end-of-Phase 2 meeting with the FDA.

On
November 17, 2021, we announced that we had received approval from the FDA to proceed with our IND application for AP-SA02.

On May 19, 2025, we announced positive topline data from the Phase 1b/2a diSArm study of intravenously administered AP-SA02 in complicatedS. aureusbacteremia.The diSArm study (NCT05184764) 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 (BAT) compared to BAT alone (placebo) for the treatment of adults 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