(RTTNews) - Armata Pharmaceuticals, Inc. (ARMP), a late-stage biotechnology company, on Tuesday, reported the conclusion of an End-of-Phase 2 written response from the U.S. Food and Drug Administration for the bacteriophage product candidate, AP-SA02.
The conclusion was backed by safety and efficacy data from Armata's Phase 2a diSArm study in complicated S. aureus bacteremia and has led Armata to plan for advancing AP-SA02 into a Phase 3 clinical study in the second half of 2026.
Following the announcement ARMP shares jumped 3.02% up at $6.80 in the pre-market.
Through the End-of-Phase 2 written response, FDA provided critical guidance on key elements of the Phase 3 study design to assess the superiority of AP-SA02 over best available antibiotic therapy for the treatment of complicated S. aureus bacteremia.
The primary study endpoint for the Phase 3 superiority study is expected to be clinical response at the end of BAT and 28 days later at the end of the study.
AP-SA02, is Armata's fixed multi-phage phage cocktail, for the treatment of complicated bacteremia caused by Staphylococcus aureus, including methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) strains.
The diSArm trial was a Phase 1b/2a study conducted across multiple centers. It used a randomized, double blind, placebo-controlled design with multiple ascending doses to evaluate the safety, tolerability, and effectiveness of intravenous AP SA02 given alongside best available antibiotic therapy or BAT and BAT alone.
According to data from the Phase 2a diSArm Study presented in October 2025, AP-SA02, combined with BAT, had a higher and earlier cure rate compared to placebo in patients with complicated SAB at day 12 along with intrinsic adaptive mechanism.
Also, no patients who received AP-SA02 were reported to show non-response or relapse at one-week post-BAT or at the end of the study.
Meanwhile, the FDA has also included recommendations for the future Biologics License Application and is amenable to accepting a Qualified Infectious Disease Product Designation request for AP-SA02, said Armata.
In addition, Armata is currently addressing FDA comments, including on Chemistry, Manufacturing, and Controls, to align with existing Phase 3 manufacturing and quality strategy.
ARMP closed Monday's trade at $6.68, 5.25% lower.
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