Armata Pharmaceuticals Highlights Positive Results from Phase 2a diSArm Study of its Staphylococcus aureus Bacteriophage Cocktail, AP-SA02, in Late-Breaking Oral Presentation at IDWeek 2025™
Armata Pharmaceuticals Highlights Positive Results from Phase 2a diSArm Study of its Staphylococcus aureus Bacteriophage Cocktail, AP-SA02, in Late-Breaking Oral Presentation at IDWeek 2025™ |
[22-October-2025] |
LOS ANGELES, Oct. 22, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today highlighted positive results from its recently completed Phase 2a diSArm study of AP-SA02 as a potential treatment for complicated Staphylococcus aureus ("S. aureus") bacteremia ("SAB") in a late-breaking oral presentation at IDWeek 2025™. The abstract, titled, "A Phase 2a Randomized, Double-Blind, Controlled Trial of the Efficacy and Safety of an Intravenous (IV) Bacteriophage Cocktail (AP-SA02) vs. Placebo in Combination with Best Available Antibiotic Therapy (BAT) in Patients with Complicated Staphylococcus aureus Bacteremia," was accepted as a highly coveted late-breaking abstract for oral presentation, and was presented by Dr. Loren G. Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute. "The results of the diSArm study confirm, for the first time in a randomized clinical trial, the efficacy of intravenous phage therapy for S. aureus bacteremia, and we are very pleased to highlight these compelling data in an oral presentation at IDWeek," stated Dr. Miller. "The results of this rigorously designed study provide strong rationale for advancement into a Phase 3 superiority study that, if successful, would support its use in clinical practice for Staphylococcus aureus bacteremia. High-purity, phage-based therapeutics like AP-SA02 have the potential to become the new standard of care for this common, extremely severe, and often deadly infection." "The positive results from the diSArm study represent another significant achievement for Armata as we aim to advance AP-SA02 into a pivotal trial," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "I would like to thank Dr. Miller and the other investigators who contributed to the efficient execution of the diSArm study, and I look forward to working with many of them on a proposed pivotal study next year. I would also like to thank Dr. Vance Fowler who served as the chair of the independent blinded adjudication committee that independently confirmed safety and efficacy findings throughout the Phase 2 trial. Finally, I would like to express my gratitude to the patients who participated in this important study, and acknowledge our partners at the U.S. Department of Defense, and our significant shareholder, Innoviva, who have each provided critical support to make this early breakthrough possible." Data highlights: The Phase 2a study enrolled and dosed 42 patients, with 29 randomized to AP-SA02 in addition to BAT and 13 to placebo (BAT alone). Methicillin-resistant S. aureus ("MRSA") was the causative pathogen in ~38% of both the AP-SA02 and placebo groups. Clinical response was assessed in the intent-to-treat (ITT) population at Test of Cure ("TOC") on day 12, one week post-BAT, and End of Study ("EOS") four weeks after BAT completion. Safety analysis also included data from the Phase 1b portion of the trial (n=8). Day 12 clinical response rates were higher in the AP-SA02 group — 88% (21/24) versus 58% (7/12) in the placebo group as assessed by blinded site investigators ("PI") (p = 0.047), and 83% (20/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by the blinded Adjudication Committee ("AC"). Non-response/relapse rates were evaluated at the two later timepoints — one week post-BAT and EOS. No patients in the AP-SA02 group experienced non-response or relapse (0%) by either PI or AC assessment. In contrast, the placebo group showed 25% non-response/relapse at both timepoints reported by the PI (p = 0.017) and 22% non-response/relapse at one week post-BAT (p = 0.025) and 25% at EOS (p = 0.02) by the AC. Patients treated with AP-SA02 showed trends toward rapid normalization of C-reactive protein, shorter time to negative blood culture, quicker time to resolution of signs and symptoms at the infection site, shorter intensive care unit and hospital utilization. AP-SA02 was well-tolerated with no serious adverse events related to the study drug. Treatment-emergent adverse events occurred in 6% (2/35) and 0% (0/15) in the AP-SA02 and placebo groups, respectively: one patient with transient liver enzyme elevation and one patient with hypersensitivity that resolved with discontinuation of vancomycin. New findings demonstrate that the defined and reproducible genomic variants present in AP-SA02 Drug Product may provide an immediate advantage, enabling rapid, strain-specific response to each patient's S. aureus isolate. These characterized variants can expand from as little as 2% to dominance when infecting certain patient isolates in vitro, highlighting that these variants are favored for their enhanced ability to infect those strains and the importance of integrating this diversity into Armata's phage cocktail from the outset. This inherent flexibility may be central to achieving optimal therapeutic efficacy. Conclusions:
About IDWeek 2025™ IDWeek 2025™ is a joint annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme "Advancing Science, Improving Care," IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2025™ takes place October 19-22 in Atlanta, GA. For more information, visit www.idweek.org. About AP-SA02 and diSArm Study 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 S. aureus bacteremia. The results from the diSArm study are an important step forward in Armata's effort to confirm the potent antimicrobial activity of phage therapy and the completion of the study represents a significant milestone in the development of AP-SA02, moving Armata one step closer to introducing an effective new treatment option to patients suffering from complicated S. aureus bacteremia. The Phase 1b/2a clinical development of AP-SA02 was partially supported by a $26.2 million Department of Defense (DoD) award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. About Armata Pharmaceuticals, Inc. Forward Looking Statements Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata: Investor Relations:
SOURCE Armata Pharmaceuticals, Inc. | ||
Company Codes: Amex:ARMP,AMEX:ARMP,NYSE:ARMP,NYSE-MKT:ARMP |