Armata advances bacteriophage therapy to phase 3 for S. aureus

-

Armata to advance bacteriophage therapy to phase 3 for S. aureus

LOS ANGELES - Armata Pharmaceuticals, Inc. (NYSE American:ARMP) announced Tuesday that the FDA has agreed that data from its Phase 2a diSArm study support advancement of AP-SA02 to Phase 3 clinical testing for complicated Staphylococcus aureus bacteremia. The biotech company, currently valued at $238.47 million, has seen its stock surge over 230% in the past year, trading at $6.68 as investors react to its clinical progress. According to InvestingPro data, analysts maintain a Strong Buy consensus on the stock with price targets ranging from $9 to $15.

The company plans to initiate the Phase 3 superiority study in the second half of 2026, following the FDA’s End-of-Phase 2 written response. The regulatory agency provided guidance on key elements of the study design, which will assess AP-SA02’s effectiveness compared to current standard of care treatments.

"The completion of our Phase 2a diSArm was the first evidence of the efficacy of phage therapy in a randomized controlled study," said Dr. Deborah Birx, Chief Executive Officer of Armata, in the press release statement.

The primary endpoint for the Phase 3 study is expected to be clinical response at the end of best available antibiotic therapy and 28 days later at the End of Study. The company is addressing FDA comments on Chemistry, Manufacturing, and Controls and has submitted a request for Qualified Infectious Disease Product Designation for AP-SA02.

AP-SA02 is a fixed multi-phage cocktail developed to treat complicated bacteremia caused by Staphylococcus aureus, including both methicillin-sensitive and methicillin-resistant strains.

The Phase 1b/2a clinical development of AP-SA02 was partially supported by a $26.2 million Department of Defense award. Results from the diSArm study were announced in May 2025 and presented at IDWeek 2025 in October.

If successful, Armata would become the first bacteriophage company to advance a clinical candidate through Phase 3 testing, potentially introducing a new treatment option for patients with complicated S. aureus bacteremia.

In other recent news, Armata Pharmaceuticals has reported significant developments that could interest investors. The company announced positive results from its Phase 2a clinical trial for its bacteriophage treatment, AP-SA02, targeting complicated Staphylococcus aureus bacteremia. In the study, patients receiving AP-SA02 in combination with standard antibiotic therapy showed an 88% clinical response rate, notably higher than the 58% response rate in the placebo group. Additionally, Armata Pharmaceuticals has commissioned a new 56,000-square-foot manufacturing facility in Los Angeles, which includes cGMP clean rooms and various laboratories, marking a step forward in their production capabilities. The U.S. Food and Drug Administration has been notified of the facility’s operational status, with full production runs already completed successfully.

Jones Trading has initiated coverage on Armata Pharmaceuticals with a Buy rating, setting a price target of $15.00. The firm highlighted Armata’s development of clinical-stage phage therapies as a key factor in its assessment. These recent developments reflect Armata’s ongoing efforts in advancing its therapeutic offerings and expanding its manufacturing infrastructure.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.


Comments

Post a Comment

Popular posts from this blog

History Part 12 : Post-War Stagnation and Phage Therapy’s Marginalization in the West (1945–1980s)

-
Image
Post-War Stagnation and Phage Therapy’s Marginalization in the West (1945–1980s) The period following World War II marked a decisive turning point in the trajectory of phage therapy in Western medicine. Despite the promising results bacteriophages had demonstrated prior to the war as potential antibacterial agents, the decades after 1945 saw a dramatic decline in interest, funding, and scientific engagement with phage therapy in the United States and much of Western Europe. This marginalization can be attributed to a confluence of scientific, sociopolitical, and economic factors that reshaped the landscape of infectious disease treatment and research. Artistic View One of the key contributors to this decline was the overwhelming optimism surrounding the newly discovered class of antibiotics. The post-war pharmaceutical revolution brought forward a series of broad-spectrum antibiotics such as streptomycin, tetracycline, and chloramphenicol, which were viewed as miracle drugs capable o...
Read more

The Phage Therapy in the spotlight !

-
Image
Bacteriophages: Ancient Predators and the Next Frontier in Medicine In the animated documentary The Deadliest Being on Planet Earth , the Kurzgesagt team delves into the world of bacteriophages—viruses that prey exclusively on bacteria. With vibrant visuals and precise narration, the video introduces viewers to an invisible ecosystem where microscopic hunters orchestrate life-and-death dramas that shape the biosphere. These entities, though virtually unknown to the general public, may soon become central to the future of medicine. At the heart of the video lies a paradox: bacteriophages (or "phages") are among the most abundant biological entities on Earth—outnumbering all other organisms combined—yet their therapeutic potential has been largely sidelined in the antibiotic era. The video outlines the historical trajectory of phage research, spotlighting Félix d’Hérelle’s early 20th-century work and the rise of phage therapy, only to show how it was later eclipsed by the dis...
Read more

Groundbreaking achievement : Phagos raises €25m to end bacterial disease

-
Image
 Phagos raises €25m to end bacterial disease  The company holds the first authorization to market personalized veterinary phage-based treatments on EU soil  ● Founded in 2021, Phagos is ushering in a new era in the fight against bacterial disease with bacteriophages, a powerful alternative to antibiotics. Thanks to an unprecedented regulatory breakthrough and a discovery platform combining microbiology and AI, Phagos offers the first phage-based drugs for veterinary use, a market worth tens of billions of dollars. The company plans to expand further as phage therapy becomes accepted in human health.                              ● The funding round was co-led by CapAgro, Hoxton Ventures, CapHorn, and Demeter alongside Acurio Ventures, Citizen Capital, Entrepreneur First, Founders Capital, and Station F.  ● Objectives: deploy veterinary treatments in the field, develop the next generation of pat...
Read more