Armata Pharmaceuticals (AMEX:ARMP) shares rose 8% after the company said the US Food and Drug Administration granted Breakthrough Therapy designation to AP-SA02, its intravenously administered Staphylococcus aureus multi-phage product candidate.
The designation covers AP-SA02 as an adjunct treatment for complicated bacteremia caused by methicillin-sensitive S. aureus, or MSSA, and methicillin-resistant S. aureus, or MRSA.
FDA Breakthrough Therapy designation is intended to expedite the development and review of treatments for serious or life-threatening conditions when preliminary clinical evidence indicates they may provide a substantial improvement over available therapies.
Designation Supported by diSArm Trial Data
The designation was supported by results from Armata’s Phase 1b/2a diSArm study in adults with complicated S. aureus bacteremia.
At the end-of-study assessment, conducted 28 days after completion of best available antibiotic therapy, 100% of patients treated with AP-SA02 maintained a clinical response without relapse, compared with 75% of patients who received placebo.
AP-SA02 was administered intravenously every six hours for five days as an adjunct to antibiotic treatment.
Armata Reports No Serious Adverse Events Attributed to AP-SA02
Armata said the dosing regimen was well tolerated, with no serious adverse events attributed to AP-SA02 during the study.
Patients receiving AP-SA02 also showed faster normalization of C-reactive protein and Interleukin-10. The company identified the two biomarkers as being associated with mortality risk and complications in S. aureus bacteremia.
AP-SA02 now has Breakthrough Therapy, Fast Track and Qualified Infectious Disease Product designations from the FDA.
Armata is developing pathogen-specific bacteriophage therapies for antibiotic-resistant and other difficult-to-treat bacterial infections.