- Armata Pharmaceuticals (ARMP, Financial) reports positive topline data from Phase 1b/2a diSArm study of AP-SA02.
- AP-SA02 showed significant improvement in treating complicated Staphylococcus aureus bacteremia.
- The study confirms safety with no treatment-related serious adverse events observed.
Armata Pharmaceuticals, Inc. (ARMP), a biotechnology firm pioneering bacteriophage therapeutics, has announced encouraging topline results from its Phase 1b/2a diSArm study concerning AP-SA02. This trial explored the intravenous administration of the novel multi-phage therapeutic in patients with complicated Staphylococcus aureus bacteremia, a severe bloodstream infection with high mortality rates.
The study, conducted with a rigorous design involving 50 participants, demonstrated that AP-SA02, when combined with best available antibiotic therapy (BAT), markedly outperformed BAT alone. At the Test of Cure timepoint, 88% of subjects treated with AP-SA02 showed a positive clinical response, significantly higher than the 58% response rate in the placebo group (p=0.047). Furthermore, by the end of the study, all patients receiving AP-SA02 had responded clinically, compared to only 75% in the placebo group (p=0.020).
Significantly, the therapy was effective against both methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) strains of the bacteria, highlighting its potential to address antibiotic-resistant infections. The absence of serious adverse events, even with a dosing frequency of every six hours over five days, underscores AP-SA02's promising safety profile.
Armata has also addressed a critical commercial challenge with the announcement of their capacity to produce 10,000 full treatment courses annually at their California manufacturing facility. This infrastructure supports the scalability of bacteriophage therapy, a crucial factor for broader clinical application and commercialization.
The successful results of this trial mark a significant milestone for Armata, potentially positioning the company as a leader in the emerging field of bacteriophage therapy. With these findings, Armata aims to advance towards a pivotal trial, with profound implications for the treatment of antibiotic-resistant infections.
